MVL
36 FDA 510(k) clearances · Product code
106 daysmedian time to decision
311 days90th percentile
36clearances measured
FDA profile
- Official device name
- Cord, Retraction
- Device class
- Unclassified
- Medical specialty
- Unknown
- Adverse events (MAUDE)
- 2012: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CyClean Cord (K254239) | SS GLOBAL | 2026-03-27 |
| One-Stop (K253797) | Mediclus Co., Ltd. | 2026-02-27 |
| Retraxil (K243910) | Kulzer, LLC | 2025-09-24 |
| Stasis Gel (K211420) | Belport Company, Inc., Gingi-Pak | 2022-03-14 |
| Gingi-Aid Gel (K211419) | Belport Company, Inc., Gingi-Pak | 2022-01-10 |
| VOCO Retraction Paste (K213149) | Voco GmbH | 2021-12-09 |
| STATSTIX (K200764) | Centrix Incorporated | 2020-10-15 |
| Vista Clear (K193389) | Inter-Med/Vista Dental Products | 2020-03-04 |
| Vista FS, Vista FS Liquid (K190220) | Inter-Med/Vista Dental Products | 2019-06-10 |
| Smartcord, Smartcord X (K171577) | Eastdent Co., Ltd. | 2018-05-03 |
| GingiDent Gingival Retraction Paste (K162662) | Pac-Dent International, Inc. | 2017-10-20 |
| Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials (K162948) | Kerr Corporation | 2017-08-08 |
| GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord (K162536) | Kerr Corporation | 2017-02-03 |
| GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord (K162164) | Kerr Corporation | 2017-01-13 |
| Astringedent Clear (K152064) | Ultradent Products, Inc. | 2015-09-24 |
| EXPAZEN (K150423) | Produits Dentaires Pierre Rolland (Acteon Group) | 2015-07-08 |
| RETRACTION PASTE (K130580) | Dmg USA, Inc. | 2014-02-25 |
| QUICKNIT (K131799) | Microcopy, Div. of Neo-Flo, Inc. | 2014-01-16 |
| KNIT-PAK+ (K132526) | Premier Dental Products Co. | 2013-11-26 |
| VISCOSTAT CLEAR (K123215) | Ultradent Products, Inc. | 2013-02-05 |
| RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (K113839) | Parkell, Inc. | 2012-04-12 |
| SULCUS BLUE (K111978) | Produits Dentaires Pierre Rolland | 2011-10-13 |
| RE / STASIS (TM) GINGIVAL RETRACTION PASTE (K111348) | Centrix, Inc. | 2011-07-22 |
| TSC (K101756) | Kerr Corporation | 2010-10-26 |
| GIRAFFE2 (K102133) | Kerr Corporation | 2010-10-07 |
| COSP2 (K093721) | 3M Espe AG Dental Products | 2010-02-19 |
| RACEGEL (K093711) | Septodont | 2010-02-17 |
| LIQUICORD (K092384) | Centrix, Inc. | 2009-11-04 |
| CORDCAP (K091380) | Centrix, Inc. | 2009-07-30 |
| TRAXODENT (K083695) | Premier Dental Products Co. | 2009-04-28 |
| HEMOSTASYL PASTE (K082116) | Satelec | 2008-12-17 |
| KORLEX-GR GINGIVAL RETRACTION PASTE (K053329) | Biotech One, Inc. | 2006-02-15 |
| EXPA-SYL (K050180) | Produits Dentaires Pierre Rolland | 2005-02-11 |
| STAY-PUT IMPREGNATED (K041023) | Coltene/Whaledent GmbH & Co. KG | 2004-06-15 |
| ULTRAPAK NEHA (K010070) | Ultradent Products, Inc. | 2001-03-15 |
| ULTRAPAK E (K981596) | Ultradent Products, Inc. | 1998-07-31 |
Track MVL automatically
Every clearance here is in the API, with alerts when new ones post.