Company ยท US
Jeneric/Pentron, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2002. Name variants (Inc, Corp, punctuation) are merged.
78510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| 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 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| ELR | Post, Root Canal | 1 |
| ELS | Splint, Endodontic Stabilizing | 1 |
| EMA | Cement, Dental | 1 |
| JEH | Plethysmograph, Volume | 1 |
| JEQ | Toothbrush, Powered | 1 |
| KIF | Resin, Root Canal Filling | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 22, 2002 | K020499 | BOND-3 ADHESIVE Jeneric/Pentron, Inc. | KLE |
| Feb 22, 2002 | K013543 | BOND-1 C & B Jeneric/Pentron, Inc. | KLE |
| Feb 14, 2002 | K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) Jeneric/Pentron, Inc. | KLE |
| Aug 23, 2001 | K012231 | AVANTE MICRO CRYSTAL SYSTEM Jeneric/Pentron, Inc. | EIH |
| Aug 3, 2001 | K011748 | FIRST FILL R.C.S. Jeneric/Pentron, Inc. | KIF |
| Jun 25, 2001 | K010957 | QUELL DESENSITIZER Jeneric/Pentron, Inc. | LBH |
| Jun 22, 2001 | K011331 | JP CAST 40 Jeneric/Pentron, Inc. | EJT |
| Jun 22, 2001 | K011330 | JP CAST 50 Jeneric/Pentron, Inc. | EJT |
| May 29, 2001 | K011362 | GOLD CORE 73 LS Jeneric/Pentron, Inc. | EJT |
| Feb 9, 2001 | K010044 | COSMIC Jeneric/Pentron, Inc. | EJT |
| Jan 11, 2001 | K003683 | AVANTE CURELIGHT Jeneric/Pentron, Inc. | EBZ |
| Dec 20, 2000 | K002854 | GOLD CORE POST SOLDER Jeneric/Pentron, Inc. | EJT |
| Dec 19, 2000 | K002815 | GOLD CORE HF PRE SOLDER Jeneric/Pentron, Inc. | EJT |
| Dec 5, 2000 | K003039 | GOLD CORE II Jeneric/Pentron, Inc. | EJH |
| Dec 5, 2000 | K003037 | JEWEL CAST III Jeneric/Pentron, Inc. | EJH |
| Nov 28, 2000 | K003011 | SELF ETCH BONDING PRIMER Jeneric/Pentron, Inc. | KLE |
| Jul 11, 2000 | K001623 | SCULPTURE FLOW Jeneric/Pentron, Inc. | EBF |
| Jul 5, 2000 | K001218 | CORRECT PLUS Jeneric/Pentron, Inc. | ELW |
| Apr 28, 2000 | K001051 | RX EVEREST Jeneric/Pentron, Inc. | EJT |
| Mar 21, 2000 | K994359 | BOND 1 C & B Jeneric/Pentron, Inc. | KLE |
| Mar 17, 2000 | K000211 | BUILD-IT FR Jeneric/Pentron, Inc. | EBF |
| Feb 29, 2000 | K000173 | CEMENT IT! UNIVERSAL C&B Jeneric/Pentron, Inc. | EMA |
| Feb 18, 2000 | K000360 | RX G-UNIVERSAL Jeneric/Pentron, Inc. | EJT |
| Feb 10, 2000 | K994435 | OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS Jeneric/Pentron, Inc. | EIH |
| Nov 29, 1999 | K993249 | OPC LOW WEAR OPAQUE PORCELAIN Jeneric/Pentron, Inc. | EIH |
| Oct 26, 1999 | K993175 | GOLD CORE 75 Jeneric/Pentron, Inc. | EJT |
| Oct 26, 1999 | K993173 | GOLD CORE 55 Jeneric/Pentron, Inc. | EJT |
| Sep 7, 1999 | K991901 | BIO-97 Jeneric/Pentron, Inc. | EJT |
| Nov 9, 1998 | K983266 | FIBREKOR POST SYSTEM Jeneric/Pentron, Inc. | ELR |
| Aug 18, 1998 | K982377 | OPC LOWWEAR PORCELAIN Jeneric/Pentron, Inc. | EIH |
| Dec 17, 1997 | K974131 | ALERT Jeneric/Pentron, Inc. | EBF |
| Sep 24, 1997 | K972985 | SPLINT IT Jeneric/Pentron, Inc. | ELS |
| Sep 12, 1997 | K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) Jeneric/Pentron, Inc. | KLE |
| Apr 16, 1997 | K970941 | SLIPPERY GLASS Jeneric/Pentron, Inc. | EIH |
| Dec 3, 1996 | K964578 | FIBREKOR Jeneric/Pentron, Inc. | EBF |
| Nov 19, 1996 | K963891 | RX 96E Jeneric/Pentron, Inc. | EJH |
| Dec 12, 1995 | K953642 | AP-18 Jeneric/Pentron, Inc. | JEH |
| Sep 27, 1995 | K953381 | PROP. CONQUEST C&B VLC GLAZE/SEALANT Jeneric/Pentron, Inc. | EBI |
| Sep 7, 1995 | K953859 | BOND-IT DUAL CURE ACTIVATOR Jeneric/Pentron, Inc. | KLE |
| Aug 28, 1995 | K952662 | COMP=FLOW Jeneric/Pentron, Inc. | EBF |
| Aug 18, 1995 | K952240 | TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION Jeneric/Pentron, Inc. | EBC |
| Jun 22, 1995 | K952500 | COMPSEAL Jeneric/Pentron, Inc. | EBF |
| Dec 29, 1994 | K945401 | WHITE STAR Jeneric/Pentron, Inc. | EJT |
| Dec 20, 1994 | K944084 | JENERIC/PENTRON P0WERED TOOTHBRUST Jeneric/Pentron, Inc. | JEQ |
| Aug 10, 1994 | K943487 | BIO74-PF CROWN & BRIDGE ALLOY Jeneric/Pentron, Inc. | EJT |
| May 3, 1994 | K941377 | CONQUEST SMOOTH TOUCH Jeneric/Pentron, Inc. | EBF |
| May 3, 1994 | K941373 | PENT CORE PLUS (PASTE-PASTE) Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941378 | PROCOM Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941376 | CONQUEST SENIOR Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941375 | CONQUEST GINGA-BLEND Jeneric/Pentron, Inc. | EBF |
Newest 50 of 78.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2009 | Jeneric/Pentron TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD,
The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent res Terminated |
EBG | K021457 |