Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EBC — Predicate Candidate Screening
131 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
165 days90th percentile
131clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260819 | Any-Com Seal | Mediclus Co., Ltd. | 2026-05-01 | 49 | 0 |
| K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc. | 2025-08-08 | 297 | 0 |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hyd | Ultradent Product, Inc. | 2023-08-18 | 1 | 0 |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | 2023-07-25 | 154 | 0 |
| K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | 2019-11-08 | 206 | 0 |
| K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | 2019-07-29 | 165 | 0 |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | 2018-01-05 | 171 | 0 |
| K171330 | Nanova Sealant | Nanova Biomaterials, Inc. | 2017-09-08 | 126 | 0 |
| K162598 | HAPI Seal | Bisco, Inc. | 2017-05-23 | 246 | 0 |
| K161580 | Premier Sealant | Premier Dental Company Products | 2016-10-18 | 132 | 0 |
| K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | 2015-03-09 | 257 | 0 |
| K130485 | CONTROL SEAL | Voco GmbH | 2014-02-11 | 351 | 0 |
| K122521 | PREVENT SEAL | Itena Clinical | 2013-06-11 | 295 | 0 |
| K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Pulpdent Corporation | 2012-03-21 | 85 | 0 |
| K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. | 2011-09-23 | 23 | 0 |
| K111782 | BEAUTISEALANT | Shofu Dental Corporation | 2011-09-16 | 84 | 0 |
| K110058 | BPA-FREE PIT AND FISSURE SEALANT | Novocol Inc. Dba Septodont and Confi-Dental Produc | 2011-03-31 | 80 | 0 |
| K102252 | DMP PIT & FISSURE SEALANT | Dmp, Ltd. | 2010-12-03 | 115 | 0 |
| K103121 | ECO-S | Vericom Co., Ltd. | 2010-10-26 | 4 | 0 |
| K101245 | ULTRASEAL ID | Ultradent Products, Inc. | 2010-09-17 | 136 | 0 |
| K100062 | INFILTRATION KIT | Dmg USA, Inc. | 2010-03-26 | 74 | 0 |
| K093059 | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT | Classone Orthodontics, Inc. | 2010-02-04 | 127 | 0 |
| K091632 | SPK SEALANT | 3M Company | 2009-09-03 | 91 | 0 |
| K083473 | CLEAR BRAVO | Denali R&D Corporation | 2009-01-22 | 59 | 0 |
| K081493 | INFILTRATION KIT | Dmg USA, Inc. | 2008-09-18 | 113 | 0 |
| K071158 | AURALAY PIT & FISSURE SEALANT | Denali Corporation | 2007-06-05 | 41 | 0 |
| K062886 | ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 | CAO Group, Inc. | 2006-11-06 | 41 | 0 |
| K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Premier Dental Products Co. | 2006-10-04 | 82 | 0 |
| K062344 | GRANDIO SEAL | Voco GmbH | 2006-10-02 | 52 | 0 |
| K061823 | ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE | Voco GmbH | 2006-07-21 | 23 | 0 |
| K052281 | EMBRACE WETBOND CLEAR SEALANT | Pulpdent Corporation | 2006-02-08 | 170 | 0 |
| K053089 | ASCENT PIT & FISSURE SEALANT | CAO Group, Inc. | 2005-12-20 | 48 | 0 |
| K051224 | BOSWORTH SEAL | Harry J. Bosworth Co. | 2005-07-28 | 77 | 0 |
| K050871 | RIVA PROTECT | Southern Dental Industries, Inc. | 2005-06-10 | 65 | 0 |
| K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING | Dentsply International | 2005-05-11 | 23 | 0 |
| K042823 | COSMEDENT PIT & FISSURE SEALANT | Cosmedent, Inc. | 2004-12-01 | 50 | 0 |
| K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP | Harry J. Bosworth Co. | 2004-02-05 | 66 | 0 |
| K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | Harry J. Bosworth Co. | 2003-09-04 | 84 | 0 |
| K021842 | ADMIRA SEAL | Voco GmbH | 2002-07-29 | 54 | 0 |
| K021844 | ADMIRA PROTECT | Voco GmbH | 2002-07-19 | 44 | 0 |
| K020287 | DENTITION INTEGRATING MATERIAL | Pulpdent Corporation | 2002-04-12 | 74 | 0 |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | 2001-11-01 | 76 | 0 |
| K012542 | REVOTEK LC | GC America, Inc. | 2001-10-16 | 70 | 0 |
| K012742 | TEETHMATE F-1 | Kuraray Medical, Inc. | 2001-09-14 | 31 | 0 |
| K011908 | OPTIBOND SOLO PLUS 3 | Kerr Dental Materials Center | 2001-09-06 | 79 | 0 |
| K011491 | HELIOSEAL CLEAR CHROMA | Ivoclar North America, Inc. | 2001-08-16 | 93 | 0 |
| K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | Rite-Dent Manufacturing Corp. | 2001-08-07 | 57 | 0 |
| K993846 | ULTRASEAL XT PLUS | Ultradent Products, Inc. | 2000-02-16 | 96 | 1 |
| K992519 | NRC NON-RINSE CONDITIONER | Dentsply Intl. | 1999-10-22 | 86 | 0 |
| K992326 | 3M CLINPRO SEALANT | 3M Company | 1999-10-08 | 87 | 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