Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MVL — Predicate Candidate Screening
36 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
311 days90th percentile
36clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254239 | CyClean Cord | SS GLOBAL | 2026-03-27 | 88 | 0 |
| K253797 | One-Stop | Mediclus Co., Ltd. | 2026-02-27 | 91 | 0 |
| K243910 | Retraxil | Kulzer, LLC | 2025-09-24 | 279 | 0 |
| K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 2022-03-14 | 311 | 0 |
| K211419 | Gingi-Aid Gel | Belport Company, Inc., Gingi-Pak | 2022-01-10 | 248 | 0 |
| K213149 | VOCO Retraction Paste | Voco GmbH | 2021-12-09 | 73 | 0 |
| K200764 | STATSTIX | Centrix Incorporated | 2020-10-15 | 205 | 0 |
| K193389 | Vista Clear | Inter-Med/Vista Dental Products | 2020-03-04 | 89 | 0 |
| K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019-06-10 | 125 | 1 |
| K171577 | Smartcord, Smartcord X | Eastdent Co., Ltd. | 2018-05-03 | 338 | 0 |
| K162662 | GingiDent Gingival Retraction Paste | Pac-Dent International, Inc. | 2017-10-20 | 389 | 0 |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chlori | Kerr Corporation | 2017-08-08 | 291 | 0 |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ | Kerr Corporation | 2017-02-03 | 144 | 0 |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-I | Kerr Corporation | 2017-01-13 | 163 | 0 |
| K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015-09-24 | 62 | 0 |
| K150423 | EXPAZEN | Produits Dentaires Pierre Rolland (Acteon Group) | 2015-07-08 | 139 | 0 |
| K130580 | RETRACTION PASTE | Dmg USA, Inc. | 2014-02-25 | 357 | 0 |
| K131799 | QUICKNIT | Microcopy, Div. of Neo-Flo, Inc. | 2014-01-16 | 211 | 0 |
| K132526 | KNIT-PAK+ | Premier Dental Products Co. | 2013-11-26 | 106 | 0 |
| K123215 | VISCOSTAT CLEAR | Ultradent Products, Inc. | 2013-02-05 | 113 | 0 |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Parkell, Inc. | 2012-04-12 | 106 | 0 |
| K111978 | SULCUS BLUE | Produits Dentaires Pierre Rolland | 2011-10-13 | 93 | 0 |
| K111348 | RE / STASIS (TM) GINGIVAL RETRACTION PASTE | Centrix, Inc. | 2011-07-22 | 70 | 0 |
| K101756 | TSC | Kerr Corporation | 2010-10-26 | 125 | 0 |
| K102133 | GIRAFFE2 | Kerr Corporation | 2010-10-07 | 70 | 0 |
| K093721 | COSP2 | 3M Espe AG Dental Products | 2010-02-19 | 79 | 0 |
| K093711 | RACEGEL | Septodont | 2010-02-17 | 78 | 0 |
| K092384 | LIQUICORD | Centrix, Inc. | 2009-11-04 | 91 | 0 |
| K091380 | CORDCAP | Centrix, Inc. | 2009-07-30 | 80 | 0 |
| K083695 | TRAXODENT | Premier Dental Products Co. | 2009-04-28 | 134 | 0 |
| K082116 | HEMOSTASYL PASTE | Satelec | 2008-12-17 | 142 | 0 |
| K053329 | KORLEX-GR GINGIVAL RETRACTION PASTE | Biotech One, Inc. | 2006-02-15 | 76 | 0 |
| K050180 | EXPA-SYL | Produits Dentaires Pierre Rolland | 2005-02-11 | 16 | 0 |
| K041023 | STAY-PUT IMPREGNATED | Coltene/Whaledent GmbH & Co. KG | 2004-06-15 | 56 | 0 |
| K010070 | ULTRAPAK NEHA | Ultradent Products, Inc. | 2001-03-15 | 66 | 0 |
| K981596 | ULTRAPAK E | Ultradent Products, Inc. | 1998-07-31 | 88 | 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