Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jeneric/Pentron, Inc. — Predicate Candidate Screening
78 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
171 days90th percentile
78clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020499 | BOND-3 ADHESIVE | Jeneric/Pentron, Inc. | 2002-04-22 | 67 | 0 |
| K013543 | BOND-1 C & B | Jeneric/Pentron, Inc. | 2002-02-22 | 128 | 0 |
| K013542 | DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) | Jeneric/Pentron, Inc. | 2002-02-14 | 120 | 0 |
| K012231 | AVANTE MICRO CRYSTAL SYSTEM | Jeneric/Pentron, Inc. | 2001-08-23 | 38 | 0 |
| K011748 | FIRST FILL R.C.S. | Jeneric/Pentron, Inc. | 2001-08-03 | 58 | 0 |
| K010957 | QUELL DESENSITIZER | Jeneric/Pentron, Inc. | 2001-06-25 | 87 | 0 |
| K011330 | JP CAST 50 | Jeneric/Pentron, Inc. | 2001-06-22 | 51 | 0 |
| K011331 | JP CAST 40 | Jeneric/Pentron, Inc. | 2001-06-22 | 51 | 0 |
| K011362 | GOLD CORE 73 LS | Jeneric/Pentron, Inc. | 2001-05-29 | 26 | 0 |
| K010044 | COSMIC | Jeneric/Pentron, Inc. | 2001-02-09 | 35 | 0 |
| K003683 | AVANTE CURELIGHT | Jeneric/Pentron, Inc. | 2001-01-11 | 43 | 0 |
| K002854 | GOLD CORE POST SOLDER | Jeneric/Pentron, Inc. | 2000-12-20 | 100 | 0 |
| K002815 | GOLD CORE HF PRE SOLDER | Jeneric/Pentron, Inc. | 2000-12-19 | 99 | 0 |
| K003037 | JEWEL CAST III | Jeneric/Pentron, Inc. | 2000-12-05 | 67 | 0 |
| K003039 | GOLD CORE II | Jeneric/Pentron, Inc. | 2000-12-05 | 67 | 0 |
| K003011 | SELF ETCH BONDING PRIMER | Jeneric/Pentron, Inc. | 2000-11-28 | 63 | 0 |
| K001623 | SCULPTURE FLOW | Jeneric/Pentron, Inc. | 2000-07-11 | 46 | 0 |
| K001218 | CORRECT PLUS | Jeneric/Pentron, Inc. | 2000-07-05 | 79 | 0 |
| K001051 | RX EVEREST | Jeneric/Pentron, Inc. | 2000-04-28 | 25 | 0 |
| K994359 | BOND 1 C & B | Jeneric/Pentron, Inc. | 2000-03-21 | 85 | 0 |
| K000211 | BUILD-IT FR | Jeneric/Pentron, Inc. | 2000-03-17 | 53 | 0 |
| K000173 | CEMENT IT! UNIVERSAL C&B | Jeneric/Pentron, Inc. | 2000-02-29 | 40 | 1 |
| K000360 | RX G-UNIVERSAL | Jeneric/Pentron, Inc. | 2000-02-18 | 14 | 0 |
| K994435 | OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS | Jeneric/Pentron, Inc. | 2000-02-10 | 42 | 0 |
| K993249 | OPC LOW WEAR OPAQUE PORCELAIN | Jeneric/Pentron, Inc. | 1999-11-29 | 62 | 0 |
| K993175 | GOLD CORE 75 | Jeneric/Pentron, Inc. | 1999-10-26 | 34 | 0 |
| K993173 | GOLD CORE 55 | Jeneric/Pentron, Inc. | 1999-10-26 | 34 | 0 |
| K991901 | BIO-97 | Jeneric/Pentron, Inc. | 1999-09-07 | 95 | 0 |
| K983266 | FIBREKOR POST SYSTEM | Jeneric/Pentron, Inc. | 1998-11-09 | 53 | 0 |
| K982377 | OPC LOWWEAR PORCELAIN | Jeneric/Pentron, Inc. | 1998-08-18 | 41 | 0 |
| K974131 | ALERT | Jeneric/Pentron, Inc. | 1997-12-17 | 44 | 0 |
| K972985 | SPLINT IT | Jeneric/Pentron, Inc. | 1997-09-24 | 44 | 0 |
| K973388 | DENTIN CONDITIONING AND ADHESIVE (BOND 1) | Jeneric/Pentron, Inc. | 1997-09-12 | 3 | 2 |
| K970941 | SLIPPERY GLASS | Jeneric/Pentron, Inc. | 1997-04-16 | 34 | 0 |
| K964578 | FIBREKOR | Jeneric/Pentron, Inc. | 1996-12-03 | 18 | 0 |
| K963891 | RX 96E | Jeneric/Pentron, Inc. | 1996-11-19 | 54 | 0 |
| K953642 | AP-18 | Jeneric/Pentron, Inc. | 1995-12-12 | 130 | 0 |
| K953381 | PROP. CONQUEST C&B VLC GLAZE/SEALANT | Jeneric/Pentron, Inc. | 1995-09-27 | 70 | 0 |
| K953859 | BOND-IT DUAL CURE ACTIVATOR | Jeneric/Pentron, Inc. | 1995-09-07 | 21 | 0 |
| K952662 | COMP=FLOW | Jeneric/Pentron, Inc. | 1995-08-28 | 77 | 0 |
| K952240 | TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION | Jeneric/Pentron, Inc. | 1995-08-18 | 98 | 0 |
| K952500 | COMPSEAL | Jeneric/Pentron, Inc. | 1995-06-22 | 23 | 0 |
| K945401 | WHITE STAR | Jeneric/Pentron, Inc. | 1994-12-29 | 56 | 0 |
| K944084 | JENERIC/PENTRON P0WERED TOOTHBRUST | Jeneric/Pentron, Inc. | 1994-12-20 | 120 | 0 |
| K943487 | BIO74-PF CROWN & BRIDGE ALLOY | Jeneric/Pentron, Inc. | 1994-08-10 | 22 | 0 |
| K941373 | PENT CORE PLUS (PASTE-PASTE) | Jeneric/Pentron, Inc. | 1994-05-03 | 42 | 0 |
| K941377 | CONQUEST SMOOTH TOUCH | Jeneric/Pentron, Inc. | 1994-05-03 | 42 | 0 |
| K941375 | CONQUEST GINGA-BLEND | Jeneric/Pentron, Inc. | 1994-05-02 | 41 | 0 |
| K941374 | CONQUEST PRELUDE | Jeneric/Pentron, Inc. | 1994-05-02 | 41 | 0 |
| K941376 | CONQUEST SENIOR | Jeneric/Pentron, Inc. | 1994-05-02 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda