Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OLR — Predicate Candidate Screening
43 FDA 510(k) clearances under this product code; the 50 most recent screened below.
122 daysmedian FDA review time
281 days90th percentile
43clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260120 | NaturaJel™ Oral Wound Care Kit | HCS Innovation, LLC | 2026-08-05 | 202 | 0 |
| K251908 | Emanate Tray | Emanate Biomedical | 2026-07-29 | 404 | 0 |
| K260126 | Curajel™ Oral Gel | USpharma, Ltd. | 2026-06-15 | 151 | 0 |
| K253816 | MuCover (proposed name) Oral Wound Dressing | MoleculeX Co., Ltd. | 2026-05-21 | 174 | 0 |
| K253758 | Dental Cone; Dental Sponge | Medizin Produkte Neustadt GmbH (Mpn) | 2025-12-18 | 23 | 0 |
| K252425 | Silatrix Oral Gel | Sa3, LLC | 2025-10-23 | 83 | 0 |
| K241283 | Elemental Granulate | Zinkh NV | 2025-01-03 | 241 | 0 |
| K230529 | HealiAid Dental Collagen Wound Dressing | Maxigen Biotech, Inc. | 2023-11-22 | 268 | 0 |
| K221428 | PerioStom Dental Dressing | Forward Science, LLC | 2022-12-22 | 220 | 0 |
| K211851 | Ora-Aid | Tbm Corporation | 2022-01-11 | 210 | 0 |
| K210211 | PuraStat-OM | 3-D Matrix, Inc. | 2021-10-08 | 254 | 0 |
| K203091 | MucoLock Oral Gel | Pcca, Inc. | 2021-02-12 | 122 | 0 |
| K202000 | Silatrix Oral Gel | Sa3, LLC | 2020-11-20 | 123 | 0 |
| K193336 | Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore an | Synedgen, Inc. | 2020-05-27 | 177 | 0 |
| K191987 | Orapeutic | Forward Science | 2019-11-27 | 125 | 0 |
| K183436 | OraCure | Tbm Corporation | 2019-09-18 | 281 | 0 |
| K173196 | SUNTOUCH Dental Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2018-01-24 | 114 | 0 |
| K130959 | AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIEL | Bioplax Limited | 2014-04-04 | 364 | 0 |
| K112568 | AONGEN DENTAL COLLAGEN MATRIX | Aeon Astron Europe B.V. | 2012-03-01 | 177 | 0 |
| K101769 | EPISIL | Camurus AB | 2011-09-13 | 446 | 0 |
| K110750 | PERIOPATCH | Mis Implants Technologies , Ltd. | 2011-04-28 | 42 | 0 |
| K103054 | PERIOPATCH | Izun Pharmaceuticals Corporation | 2011-02-07 | 115 | 0 |
| K090612 | BENACEL | Unicare Biomedical | 2009-07-24 | 140 | 0 |
| K081372 | GELX ORAL GEL | Bmg Pharma, LLC | 2009-02-04 | 264 | 0 |
| K082553 | REXASTOM ORAL EASE | Rexaderm, Inc. | 2008-11-21 | 79 | 0 |
| K082856 | CARAPASTE ORAL WOUND DRESSING | Mcgrath Pharmaceuticals, Inc. | 2008-10-15 | 16 | 0 |
| K070842 | ULCELOOCIN ORAL ULCER PATCH | Sunshine International Group, Inc. | 2007-06-07 | 72 | 0 |
| K053342 | GENGIGEL MOUTHRINSE | Ricerfarma Srl | 2007-03-13 | 467 | 0 |
| K063148 | SOCK IT! ORAL PAIN GEL | Merlin Group Dba Mcmerlin Dental Company | 2007-01-17 | 93 | 0 |
| K062795 | MUGARD MUCOADHESIVE ORAL WOUND RINSE | Access Pharmaceuticals, Inc. | 2006-12-11 | 84 | 0 |
| K060363 | HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, | Hemcon, Inc. | 2006-07-07 | 144 | 0 |
| K060340 | ORAMAGIC PLUS ORAL WOUND RINSE | Mpm Medical., Inc. | 2006-05-10 | 89 | 0 |
| K042722 | ALOCLAIR ORAL SPRAY | Sinclair Pharmaceuticals, Ltd. | 2005-01-13 | 104 | 0 |
| K042400 | MUCOTROL CONCENTRATED ORAL GEL WAFER | Belcher Pharmaceuticals, Inc. | 2004-11-24 | 82 | 1 |
| K040950 | ALOCLAIR ORAL GEL | Sinclair Pharmaceuticals, Ltd. | 2004-06-21 | 70 | 0 |
| K024180 | ORAMAGICRX ORAL WOUND RINSE | Mpm Medical., Inc. | 2003-03-14 | 86 | 0 |
| K023155 | ALOCLAIR ORAL RINSE | Sinclair Pharmaceuticals, Ltd. | 2002-11-25 | 63 | 0 |
| K013056 | GELCLAIR CONCENTRATED ORAL GEL | Sinclair Pharmaceuticals, Ltd. | 2001-12-21 | 101 | 0 |
| K012126 | THE SALICEPT ORAL PATCH | Carrington Laboratories, Inc. | 2001-10-03 | 89 | 0 |
| K983182 | ALOE THERAPY ORAL RINSE | Carrington Laboratories, Inc. | 1998-12-10 | 90 | 0 |
| K964852 | RADIACARE ORAL WOUND RINSE | Carrington Laboratories, Inc. | 1997-03-03 | 90 | 0 |
| K953423 | CASRRASYN ORAL WOUND DRESSING | Carrington Laboratories, Inc. | 1995-10-11 | 113 | 0 |
| K933741 | CARRASYN ORAL WOUND DRESSING | Carrington Laboratories, Inc. | 1994-05-04 | 274 | 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