Jeneric/Pentron, Inc.
Medical device manufacturer in Wallingford, CT.
78510(k) clearances
0PMA approvals
1recalls
Device types
- EBF Material, Tooth Shade, Resin 15
- EJT Alloy, Gold-Based Noble Metal 13
- EJS Alloy, Other Noble Metal 10
- KLE Agent, Tooth Bonding, Resin 9
- EJH Alloy, Metal, Base 6
- EIH Powder, Porcelain 5
- ELW Material, Impression 4
- EJJ Alloy, Amalgam 3
- ELL Teeth, Porcelain 2
- KIF Resin, Root Canal Filling 1
- LBH Varnish, Cavity 1
- EBZ Activator, Ultraviolet, For Polymerization 1
- EMA Cement, Dental 1
- ELR Post, Root Canal 1
- ELS Splint, Endodontic Stabilizing 1
- JEH Plethysmograph, Volume 1
- EBI Resin, Denture, Relining, Repairing, Rebasing 1
- EBC Sealant, Pit And Fissure, And Conditioner 1
- JEQ Toothbrush, Powered 1
- DYH Adhesive, Bracket And Tooth Conditioner… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K020499 | BOND-3 AdhesiveKLE · Traditional | 04/22/2002SE |
| K013543 | BOND-1 C & BKLE · Traditional | 02/22/2002SE |
| K013542 | Dentin Conditioning and Adhesive System (BOND-1)KLE · Traditional | 02/14/2002SE |
| K012231 | Avante Micro Crystal SystemEIH · Traditional | 08/23/2001SE |
| K011748 | First Fill R.C.S.KIF · Traditional | 08/03/2001SE |
| K010957 | Quell DesensitizerLBH · Traditional | 06/25/2001SE |
| K011331 | JP Cast 40EJT · Traditional | 06/22/2001SE |
| K011330 | JP Cast 50EJT · Traditional | 06/22/2001SE |
| K011362 | Gold Core 73 LSEJT · Traditional | 05/29/2001SE |
| K010044 | CosmicEJT · Traditional | 02/09/2001SE |
| K003683 | Avante CurelightEBZ · Traditional | 01/11/2001SE |
| K002854 | Gold Core Post SolderEJT · Traditional | 12/20/2000SE |
| K002815 | Gold Core HF Pre SolderEJT · Traditional | 12/19/2000SE |
| K003039 | Gold Core IIEJH · Traditional | 12/05/2000SE |
| K003037 | Jewel Cast IIIEJH · Traditional | 12/05/2000SE |
| K003011 | Self Etch Bonding PrimerKLE · Traditional | 11/28/2000SE |
| K001623 | Sculpture FlowEBF · Traditional | 07/11/2000SE |
| K001218 | Correct PlusELW · Traditional | 07/05/2000SE |
| K001051 | RX EverestEJT · Traditional | 04/28/2000SE |
| K994359 | Bond 1 C & BKLE · Traditional | 03/21/2000SE |
| K000211 | Build-It FREBF · Traditional | 03/17/2000SE |
| K000173 | Cement It! Universal C&BEMA · Traditional | 02/29/2000SE |
| K000360 | RX G-UniversalEJT · Traditional | 02/18/2000SE |
| K994435 | Opc 3G All-Ceramic System, Core and Overlay PorcelainsEIH · Traditional | 02/10/2000SE |
| K993249 | Opc Low Wear Opaque PorcelainEIH · Traditional | 11/29/1999SE |
| K993175 | Gold Core 75EJT · Traditional | 10/26/1999SE |
| K993173 | Gold Core 55EJT · Traditional | 10/26/1999SE |
| K991901 | BIO-97EJT · Traditional | 09/07/1999SE |
| K983266 | Fibrekor Post SystemELR · Traditional | 11/09/1998SE |
| K982377 | Opc Lowwear PorcelainEIH · Traditional | 08/18/1998SE |
| K974131 | AlertEBF · Traditional | 12/17/1997SE |
| K972985 | Splint ItELS · Traditional | 09/24/1997SE |
| K973388 | Dentin Conditioning and Adhesive (Bond 1)KLE · Traditional | 09/12/1997SE |
| K970941 | Slippery GlassEIH · Traditional | 04/16/1997SE |
| K964578 | FibrekorEBF · Traditional | 12/03/1996SE |
| K963891 | RX 96EEJH · Traditional | 11/19/1996SE |
| K953642 | AP-18JEH · Traditional | 12/12/1995SE |
| K953381 | Prop. Conquest C&B VLC Glaze/SealantEBI · Traditional | 09/27/1995SE |
| K953859 | Bond-It Dual Cure ActivatorKLE · Traditional | 09/07/1995SE |
| K952662 | Comp=FlowEBF · Traditional | 08/28/1995SE |
| K952240 | Tooth Preparation Conditioner, Pre-ImpressionEBC · Traditional | 08/18/1995SE |
| K952500 | CompsealEBF · Traditional | 06/22/1995SE |
| K945401 | White StarEJT · Traditional | 12/29/1994SE |
| K944084 | Jeneric/Pentron P0WERED ToothbrustJEQ · Traditional | 12/20/1994SE |
| K943487 | BIO74-PF Crown & Bridge AlloyEJT · Traditional | 08/10/1994SE |
| K941377 | Conquest Smooth TouchEBF · Traditional | 05/03/1994SE |
| K941373 | Pent Core Plus (Paste-Paste)EBF · Traditional | 05/03/1994SE |
| K941378 | ProcomEBF · Traditional | 05/02/1994SE |
| K941376 | Conquest SeniorEBF · Traditional | 05/02/1994SE |
| K941375 | Conquest Ginga-BlendEBF · Traditional | 05/02/1994SE |
| K941374 | Conquest PreludeEBF · Traditional | 05/02/1994SE |
| K936222 | Dentin Conditioning and Adhesive SystemKLE · Traditional | 03/15/1994SE |
| K934758 | R2+EJH · Traditional | 02/18/1994SE |
| K934757 | Cu-Free & LtaEJS · Traditional | 02/04/1994SE |
| K932154 | Conquest CrystalEBF · Traditional | 09/15/1993SE |
| K922954 | R1, R2, and R1+EJH · Traditional | 07/22/1993SE |
| K926147 | Gold-Platinum Based Casting AlloyEJS · Traditional | 05/27/1993SE |
| K926146 | Bio C & BEJS · Traditional | 05/27/1993SE |
| K925331 | Correct and Correct Fit IIEJS · Traditional | 05/27/1993SE |
| K926145 | Nugold 2%EJS · Traditional | 05/05/1993SE |
| K922958 | KB58-KFEJS · Traditional | 02/26/1993SE |
| K922955 | Zenon PlusEJS · Traditional | 12/23/1992SE |
| K921283 | Adhesive, Bracket and Tooth Conditioner ResinDYH · Traditional | 12/23/1992SE |
| K922957 | ParagonEJS · Traditional | 09/14/1992SE |
| K922956 | KB40-KFEJS · Traditional | 09/14/1992SE |
| K923202 | Q3 (Light and Universal) Impression MaterialELW · Traditional | 08/27/1992SE |
| K914178 | Corrected-V.P.S.ELW · Traditional | 04/28/1992SE |
| K914437 | Correct-S.I.M.ELW · Traditional | 01/17/1992SE |
| K910569 | TyceramicELL · Traditional | 04/15/1991SE |
| K910303 | Sysnpar PorcelainELL · Traditional | 03/08/1991SE |
| K904724 | Conquest Direct Filling Composite (DFC)KLE · Traditional | 12/07/1990SE |
| K894644 | Crown and Bridge Dental Restorative Composite SystEBF · Traditional | 10/20/1989SE |
| K890662 | Pent CapsEJJ · Traditional | 05/09/1989SE |
| K890682 | Orosphere PlusEJJ · Traditional | 05/05/1989SE |
| K890681 | Orosphere HCDPEJJ · Traditional | 05/02/1989SE |
| K890811 | RX Apf (Casting Alloy)EJS · Traditional | 03/17/1989SE |
| K884038 | Fiberlite, Fiberlite HS and FibersealEBF · Traditional | 12/07/1988SE |
| K882170 | RX AspenEJH · Traditional | 06/17/1988SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0482-2010 | TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended…Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary… | 10/22/2009Terminated |