Kerr Corporation
Medical device manufacturer in Pomona, CA.
41510(k) clearances
0PMA approvals
54recalls
Device types
- EBF Material, Tooth Shade, Resin 9
- ELW Material, Impression 8
- EBZ Activator, Ultraviolet, For Polymerization 6
- MVL Cord, Retraction 5
- KLE Agent, Tooth Bonding, Resin 4
- EMA Cement, Dental 3
- KIF Resin, Root Canal Filling 2
- NTK Light Transmission Caries Detector 1
- MZW Dental Cement W/Out Zinc-Oxide Eugenol As… 1
- EBG Crown And Bridge, Temporary, Resin 1
- NYL Handpiece, Air-Powered, Root Canal Irrigation 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K252890 | ZenSeal ProKIF · Traditional | 01/07/2026SE |
| K222830 | Rainbow 360KLE · Traditional | 01/12/2023SE |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill FlowEBF · Traditional | 08/31/2022SE |
| K191548 | Nexus Universal Self-CureEMA · Traditional | 10/11/2019SE |
| K182162 | OptiBond eXTRa UniversalKLE · Traditional | 11/07/2018SE |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction…MVL · Traditional | 08/08/2017SE |
| K163064 | Demi UltraEBZ · Special | 07/18/2017SE |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum…MVL · Traditional | 02/03/2017SE |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordMVL · Traditional | 01/13/2017SE |
| K162436 | EndoVac PureNYL · Traditional | 12/21/2016SE |
| K162257 | P1145 Dental RestorativeEBF · Traditional | 11/07/2016SE |
| K160441 | Identic and KromaFaze Alginate Dental Impression MaterialsELW · Traditional | 06/30/2016SE |
| K123468 | Demi UltraEBZ · Traditional | 03/20/2013SE |
| K123595 | Nexus RmgiEMA · Traditional | 02/19/2013SE |
| K110747 | TempflexEBG · Traditional | 06/14/2011SE |
| K110092 | Take 1 Advanced Rigid TrayELW · Traditional | 04/08/2011SE |
| K102621 | SolsticeEBZ · Traditional | 01/28/2011SE |
| K103351 | DMC Composite 2EBF · Traditional | 01/20/2011SE |
| K101756 | TSCMVL · Traditional | 10/26/2010SE |
| K102163 | Realseal XT SealerKIF · Traditional | 10/16/2010SE |
| K102133 | GIRAFFE2MVL · Traditional | 10/07/2010SE |
| K101423 | Optibond XTRKLE · Traditional | 07/30/2010SE |
| K100347 | Optibond SeKLE · Traditional | 04/30/2010SE |
| K100083 | EstheticaEBF · Traditional | 03/19/2010SE |
| K092176 | Take 1 Advanced Rigid TrayELW · Traditional | 01/28/2010SE |
| K093484 | Premise Flowable ModifiedEBF · Traditional | 01/27/2010SE |
| K091613 | Take 1ELW · Traditional | 10/07/2009SE |
| K091023 | MetamorphosisEBF · Traditional | 05/21/2009SE |
| K090292 | Premise ModifiedEBF · Traditional | 04/03/2009SE |
| K081695 | DMC CompositeEBF · Traditional | 08/12/2008SE |
| K073209 | Maxcem 2MZW · Traditional | 01/29/2008SE |
| K072622 | Standout 2ELW · Traditional | 12/04/2007SE |
| K071429 | TI2200 Transillumination CableNTK · Traditional | 09/10/2007SE |
| K071251 | DemiEBZ · Traditional | 07/26/2007SE |
| K062519 | Nexus 3EMA · Traditional | 10/19/2006SE |
| K060472 | Premise FlowableEBF · Traditional | 04/28/2006SE |
| K042888 | Demetron Ids Curing LightEBZ · Traditional | 11/10/2004SE |
| K031484 | Stand OutELW · Traditional | 07/03/2003SE |
| K014179 | Demetron LCEBZ · Traditional | 02/04/2002SE |
| K010994 | Take One Bite ModifiedELW · Traditional | 04/23/2001SE |
| K001655 | Permlastic 2ELW · Traditional | 08/10/2000SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1788-2014 Class II | Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The…Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294)… | 05/29/2014Terminated |
| Z-0401-2013 Class II | BioPlant, a dental bone grafting material. BioPlant has been assigned the product code…The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or… | 10/25/2012Terminated |
| Z-0414-2013 Class II | The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection.…The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser… | 04/10/2012Terminated |
| Z-0268-2013 Class II | The brand name of the device is AlgiNot, a dental impression material. Product Part…The firm recalled the product because it may cure harder than expected within the shelf life, which could… | 02/21/2012Terminated |
| Z-0402-2013 Class II | Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number…The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect… | 11/17/2011Terminated |
| Z-1205-2012 | Brand Name: TempSpan CMT Temporary Cement, a temporary cement. Part Number: N69CA. The…The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have… | 03/03/2011Terminated |
| Z-0455-2012 | Artiste Maverick Tint, Part Number: N36TB, Lot/Serial Numbers: 3416180, Product…The resin material separates when the product is extruded from the syringe. Although there are no safety… | 03/03/2011Terminated |
| Z-0915-2012 | Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use…The recall was initiated because Kerr Corporation has confirmed that the use of the affected lot of Maxcem… | 02/03/2011Terminated |
| Z-1100-2012 | Breeze Self-Adhesive Resin Cement, part number: N97F. The intended use is for…The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement… | 12/02/2010Terminated |
| Z-1115-2012 | Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC. Product Usage: The intended…A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as… | 08/19/2010Terminated |
| Z-1142-2012 | Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description…The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive… | 05/27/2010Terminated |
| Z-0074-2010 | Kerr TempBond Clear, Part # 33351, 1717 West Collins Avenue, Orange, CA 92867. Intended…The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making… | 09/09/2009Terminated |
| Z-0270-2009 | PREMISE KIT, PART NO. 33882, UNIDOSE PREMISE MINI KIT, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0269-2009 | PREMISE KIT, PART NO. 32612, UNIDOSE PREMISE MASTER KIT, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0268-2009 | PREMISE, PART NO. 32837, 10 PACK UNIDOSE PREMISA TRANSLUCENT AMBER (INTERNATIONAL ONLY)…Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0267-2009 | PREMISE, PART NO. 32830, 10 PACK UNIDOSE PREMISA DESTIN A3 (INTERNATIONAL ONLY), dental…Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0266-2009 | PREMISE, PART NO. 32824, 10 PACK UNIDOSE PREMISA D2 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0265-2009 | PREMISE, PART NO. 32823, 10 PACK UNIDOSE PREMISA C4 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0264-2009 | PREMISE, PART NO. 32822, 10 PACK UNIDOSE PREMISA C3 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0263-2009 | PREMISE, PART NO. 32818, 10 PACK UNIDOSE PREMISA B3 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0262-2009 | PREMISE, PART NO. 32817, 10 PACK UNIDOSE PREMISA B2 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0261-2009 | PREMISE, PART NO. 32815, 10 PACK UNIDOSE PREMISA A4 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0260-2009 | PREMISE, PART NO. 32814, 10 PACK UNIDOSE PREMISA A3.5 (INTERNATIONAL ONLY), dental…Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0259-2009 | PREMISE, PART NO. 32813, 10 PACK UNIDOSE PREMISA A3 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0258-2009 | PREMISE, PART NO. 32812, 10 PACK UNIDOSE PREMISA A2 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0257-2009 | PREMISE, PART NO. 32811, 10 PACK UNIDOSE PREMISA A1 (INTERNATIONAL ONLY), dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0256-2009 | PREMISE, PART NO. 34086, 10 PACK UNIDOSE PREMISE A2 SAMPLE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0255-2009 | PREMISE, PART NO. 32678, 10 PACK UNIDOSE PREMISE TRANS CLEAR, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0254-2009 | PREMISE, PART NO. 32677, 10 PACK UNIDOSE PREMISE TRANS GREY, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0253-2009 | PREMISE, PART NO. 32676, 10 PACK UNIDOSE PREMISE TRANS AMBER, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0252-2009 | PREMISE, PART NO. 32674, 10 PACK UNIDOSE PREMISE C2 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0251-2009 | PREMISE, PART NO. 32673, 10 PACK UNIDOSE PREMISE B2 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0250-2009 | PREMISE, PART NO. 32672, 10 PACK UNIDOSE PREMISE B1 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0249-2009 | PREMISE, PART NO. 32670, 10 PACK UNIDOSE PREMISE A3.5 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0248-2009 | PREMISE, PART NO. 32669, 10 PACK UNIDOSE PREMISE A3 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0247-2009 | PREMISE, PART NO. 32668, 10 PACK UNIDOSE PREMISE A2 OPAQUE, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0246-2009 | PREMISE, PART NO. 32667, 10 PACK UNIDOSE PREMISE XL2, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0245-2009 | PREMISE, PART NO. 32666, 10 PACK UNIDOSE PREMISE XL1, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0244-2009 | PREMISE, PART NO. 32665, 10 PACK UNIDOSE PREMISE D4, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0243-2009 | PREMISE, PART NO. 32664, 10 PACK UNIDOSE PREMISE D3, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0242-2009 | PREMISE, PART NO. 32663, 10 PACK UNIDOSE PREMISE D2, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0241-2009 | PREMISE, PART NO. 32662, 10 PACK UNIDOSE PREMISE C4, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0240-2009 | PREMISE, PART NO. 32661, 10 PACK UNIDOSE PREMISE C3, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0239-2009 | PREMISE, PART NO. 32660, 10 PACK UNIDOSE PREMISE C2, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0238-2009 | PREMISE, PART NO. 32659, 10 PACK UNIDOSE PREMISE C1, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0237-2009 | PREMISE, PART NO. 32658, 10 PACK UNIDOSE PREMISE B4, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0236-2009 | PREMISE, PART NO. 32657, 10 PACK UNIDOSE PREMISE B3, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0235-2009 | PREMISE, PART NO. 32656, 10 PACK UNIDOSE PREMISE B2, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0234-2009 | PREMISE, PART NO. 32655, 10 PACK UNIDOSE PREMISE B1, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0233-2009 | PREMISE, PART NO. 32654, 10 PACK UNIDOSE PREMISE A4, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0232-2009 | PREMISE, PART NO. 32653, 10 PACK UNIDOSE PREMISE A3.5, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0231-2009 | PREMISE, PART NO. 32652, 10 PACK UNIDOSE PREMISE A3, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0230-2009 | PREMISE, PART NO. 32651, 10 PACK UNIDOSE PREMISE A2, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |
| Z-0229-2009 | PREMISE, PART NO. 32650, 10 PACK UNIDOSE PREMISE A1, dental compositeMaterial stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to… | 09/05/2008Terminated |