Coltene/Whaledent, Inc.
Medical device manufacturer in Cuyahoga Falls, OH.
40510(k) clearances
0PMA approvals
15recalls
Device types
- EBF Material, Tooth Shade, Resin 10
- EMA Cement, Dental 9
- KLE Agent, Tooth Bonding, Resin 4
- ELW Material, Impression 3
- ELR Post, Root Canal 3
- EBZ Activator, Ultraviolet, For Polymerization 3
- ELC Scaler, Ultrasonic 2
- FRG Wrap, Sterilization 2
- KIF Resin, Root Canal Filling 1
- MVL Cord, Retraction 1
- KMH Sterilizer, Dry Heat 1
- EKZ Unit, Electrosurgical, And Accessories… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K191385 | Brilliant ComponeerEBF · Traditional | 10/29/2019SE |
| K190597 | BRILLIANT EverGlow FlowEBF · Traditional | 06/21/2019SE |
| K181500 | BRILLIANT CriosEBF · Traditional | 08/15/2018SE |
| K160800 | DuoCemEMA · Traditional | 11/16/2016SE |
| K152927 | Brilliant EverglowEBF · Traditional | 04/28/2016SE |
| K152243 | One Coat 7 UniversalKLE · Traditional | 12/09/2015SE |
| K150218 | Fill-Up!EBF · Traditional | 06/23/2015SE |
| K130137 | Biosonic Suvi Piezeoelectric Scaler and PolisherELC · Traditional | 08/23/2013SE |
| K121621 | SolocemEMA · Traditional | 01/08/2013SE |
| K112168 | ComponeerEBF · Traditional | 11/21/2011SE |
| K083304 | Temposil 2EMA · Traditional | 02/06/2009SE |
| K072604 | Duo TempEMA · Traditional | 11/16/2007SE |
| K071632 | Perfect Tissue Contouring System IIEKZ · Abbreviated | 10/18/2007SE |
| K052820 | Parapost Paracore Automix 5MLEBF · Traditional | 01/09/2006SE |
| K053040 | Paracem Universal DCEMA · Traditional | 11/09/2005SE |
| K051660 | Dentronix DDS 7000 Rapid Dry Heat Sterilizer Sterilization SystemKMH · Traditional | 08/04/2005SE |
| K051243 | Jet Blue BiteELW · Traditional | 06/23/2005SE |
| K050426 | Temposil, Model 6720EMA · Traditional | 03/18/2005SE |
| K050013 | RetractofoamELW · Traditional | 02/09/2005SE |
| K041023 | Stay-Put ImpregnatedMVL · Traditional | 06/15/2004SE |
| K040551 | Coltolux LED Curing LightEBZ · Traditional | 03/15/2004SE |
| K033760 | One Coat Se BondKLE · Traditional | 01/23/2004SE |
| K032662 | GuttaflowKIF · Traditional | 11/03/2003SE |
| K031752 | Coltosol FEMA · Traditional | 08/05/2003SE |
| K013400 | Synergy FlowEBF · Traditional | 12/10/2001SE |
| K003034 | Coltene Aura Compomer Restorative SystemEBF · Traditional | 11/30/2000SE |
| K993545 | Tenax White PostELR · Traditional | 04/14/2000SE |
| K000311 | Parapost Fiber WhiteELR · Traditional | 03/14/2000SE |
| K993710 | Modification of Parapost CementEMA · Traditional | 12/21/1999SE |
| K993835 | Parapost System Sterilizable OrganizerFRG · Traditional | 12/16/1999SE |
| K993255 | Biosonic UC-70 Sterilizable Instrument CassetteFRG · Traditional | 12/06/1999SE |
| K983727 | Biosonic Ultrasonic Scaler SystemELC · Traditional | 01/20/1999SE |
| K974906 | One Coat Bond Dentin/Enamel Adhesive SystemKLE · Traditional | 03/24/1998SE |
| K974465 | SynergyEBF · Traditional | 03/09/1998SE |
| K950106 | Coltolux Light MeterEBZ · Traditional | 05/24/1995SE |
| K945698 | Coltolux 3, Coltolux 4EBZ · Traditional | 05/24/1995SE |
| K945366 | Parapost CementEMA · Traditional | 02/02/1995SE |
| K934192 | Parapost XT SystemELR · Traditional | 06/06/1994SE |
| K922615 | Coltene A.R.T. BondKLE · Traditional | 08/03/1992SE |
| K912485 | Coltene President Jet Light/Reg Body HydrophilicELW · Traditional | 07/25/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1208-2023 Class II | SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material…Screw connection between the turbine head and the push button may loosen and fall off during the treatment… | 01/20/2023Open, Classified |
| Z-1494-2021 Class II | Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the…The incorrect dental pins were packaged and subsequently distributed. | 03/18/2021Open, Classified |
| Z-0468-2021 Class II | Strauss 25 Carbide Dental Burs (100057XXV)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0467-2021 Class II | CEI Cutting Edge Instruments (PTC-57C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0466-2021 Class II | Clinic Pack 100 Pieces FG 57 100057C (100057C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0465-2021 Class II | FG 57 100057X (100057X)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-0464-2021 Class II | Alpen Clinic 100 Carbide Instruments (R100057C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | 10/20/2020Open, Classified |
| Z-2422-2020 Class II | HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps…Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult… | 06/03/2020Open, Classified |
| Z-2421-2020 Class II | HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are…Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult… | 06/03/2020Open, Classified |
| Z-2420-2020 Class II | HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are…Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult… | 06/03/2020Open, Classified |
| Z-2419-2020 Class II | HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are…Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult… | 06/03/2020Open, Classified |
| Z-2436-2019 Class II | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-FA single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the… | 07/19/2019Terminated |
| Z-0376-2019 Class II | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B…ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 | 08/21/2018Terminated |
| Z-1883-2018 Class II | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a…The products are labeled with an incorrect product number. | 04/13/2018Terminated |
| Z-2151-2014 Class II | Latex Dental Dams labeled as Non-Latex Dental DamsColtne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an… | 12/11/2013Terminated |