Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBD — Predicate Candidate Screening
52 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
240 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254091 | GLOSSY COAT (15ML) | YAMAHACHI DENTAL MFG., Co. | 2026-04-06 | 108 | 0 |
| K250804 | ID LIGHT CURE SYSTEM | Id Korea Co., Ltd. | 2025-06-04 | 79 | 0 |
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | 2024-12-12 | 269 | 0 |
| K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | 2023-03-27 | 144 | 0 |
| K211854 | VITA Akzent LC | Vita Zahnfabrik GmbH H Rauter & CO | 2021-11-22 | 159 | 0 |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | 2018-04-05 | 584 | 0 |
| K163568 | SHOFU RESIN GLAZE | Shofu Dental Corporation | 2017-08-16 | 240 | 0 |
| K133836 | OPTIGLAZE COLOR | GC America, Inc. | 2014-03-06 | 78 | 0 |
| K123761 | VITA ENAMIC STAINS | Innovation Meditech GmbH | 2013-03-01 | 84 | 0 |
| K093019 | ENAMELITE ACRYSEAL SPRAY SEALANT | Enamelite, LLC | 2009-12-22 | 84 | 0 |
| K082285 | EASY GLAZE | Voco GmbH | 2008-10-24 | 74 | 0 |
| K080549 | DURAFINISH ALL-CURE, MODEL S296 | Parkell, Inc. | 2008-05-13 | 76 | 0 |
| K073243 | LED PRO SEAL | Reliance Orthodontic Products, Inc. | 2008-02-08 | 81 | 0 |
| K070306 | PAINT- ON POLISH AGENT | Dentsply International, Inc. | 2007-03-22 | 49 | 0 |
| K063228 | SURFACE COAT | Kuraray America, Inc. | 2006-12-08 | 44 | 0 |
| K052462 | G-COAT | GC America, Inc. | 2005-10-20 | 42 | 0 |
| K051999 | BISCOVER LED | Bisco, Inc. | 2005-08-22 | 28 | 0 |
| K043168 | BISCOVER LV | Bisco, Inc. | 2005-02-01 | 77 | 0 |
| K040599 | PARKELL RESIN GLAZE | Parkell, Inc. | 2004-04-09 | 32 | 0 |
| K030646 | BELLEGLASS POINT 4 | Kerr Dental Materials Center | 2003-05-06 | 67 | 0 |
| K030585 | SCULPTING RESIN | Bisco, Inc. | 2003-04-28 | 63 | 0 |
| K030354 | BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCO | Bisco, Inc. | 2003-02-19 | 16 | 0 |
| K024046 | TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93 | Bisco, Inc. | 2003-02-06 | 62 | 0 |
| K021503 | UNINHIBITED | Bisco, Inc. | 2002-08-01 | 84 | 0 |
| K011239 | GINDA GUARD | Cosmedent, Inc. | 2002-02-14 | 297 | 0 |
| K013179 | LUXAGLAZE | Dmg USA, Inc. | 2001-10-12 | 18 | 0 |
| K992067 | BELLEGLAZE | Kerr Dental Materials Center | 1999-08-27 | 70 | 0 |
| K984037 | CORE-IDE | Roydent Dental Products, Inc. | 1999-02-04 | 84 | 0 |
| K980298 | FLOWABLE HYBRID | Cosmedent, Inc. | 1998-03-09 | 41 | 0 |
| K974494 | RENAMEL FLOWABLE COMPOSITE | Cosmedent, Inc. | 1998-02-10 | 74 | 0 |
| K935689 | IONOSIT BASE LINER | Foremost Dental Mfg., Co. | 1994-01-21 | 53 | 0 |
| K904135 | FOUNDATION HYBRID COMPOSITE | Nulite Systems Research | 1991-05-15 | 251 | 0 |
| K901050 | NO-STICK COMPOSITE INSTRUMENT DIP | Pulpdent Corp. | 1990-04-19 | 45 | 0 |
| K862590 | 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) | 3M Company | 1986-07-22 | 15 | 0 |
| K854957 | AUSTENAL DENTAL COMPOSITE RESIN | Austenal Dental, Inc. | 1986-01-30 | 50 | 0 |
| K844845 | ESPE KETAC-BOND | Espe GmbH (Us) | 1985-08-19 | 249 | 0 |
| K850610 | PEPSODENT DENTURE ADHESIVE CREAM | Lever Brothers Company, Inc. | 1985-05-15 | 89 | 0 |
| K850675 | CURAY JOIN DENT DENTIN PRIMER | Scientific Pharmaceuticals, Inc. | 1985-03-25 | 32 | 0 |
| K850641 | CAULK DYCAL LIGHT CURED | Dentsply Intl. | 1985-03-18 | 27 | 0 |
| K850073 | J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT | Johnson & Johnson Professionals, Inc. | 1985-02-08 | 30 | 0 |
| K840751 | OPAQUE COATING & SURFACE STAIN | Dentsply Intl. | 1984-05-11 | 78 | 0 |
| K832834 | CONCISE 2 SMALL PARTICLE LIGHT CURVED | 3M Company | 1983-09-29 | 41 | 0 |
| K823732 | CBM, CORE BUILD-UP MATERIAL | Scientific Pharmaceuticals, Inc. | 1982-12-28 | 18 | 0 |
| K822869 | COMMAND BONDING RESIN/GLAZE/OPAQUER | Sybron Corp. | 1982-10-13 | 16 | 0 |
| K822714 | CONCLUDE COMPOSITE LUTING CEMENT | 3M Company | 1982-09-28 | 21 | 0 |
| K813328 | MYERSON/KENSON GP POLYMER | Howmedica Corp. | 1982-02-24 | 92 | 0 |
| K810813 | DMG-POLISHABLE COMPOSITE | Dental-Material Gesellschaft | 1981-04-14 | 21 | 0 |
| K791078 | ANTERIOR/POSTERIOR RESTORATIVE, BOND | Scientific Pharmaceuticals, Inc. | 1979-08-10 | 59 | 0 |
| K791067 | SCI-PHARM PAINT-ON RESTORATIVE | Scientific Pharmaceuticals, Inc. | 1979-08-10 | 59 | 0 |
| K790438 | COLORANT | Vivadent (Usa), Inc. | 1979-04-10 | 34 | 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