Product code MVL
- Device name
- Cord, Retraction
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254239 | CyClean Cord | SS GLOBAL | 2026-03-27 |
| K253797 | One-Stop | Mediclus Co., Ltd. | 2026-02-27 |
| K243910 | Retraxil | Kulzer, LLC | 2025-09-24 |
| K211420 | Stasis Gel | Belport Company, Inc., Gingi-Pak | 2022-03-14 |
| K211419 | Gingi-Aid Gel | Belport Company, Inc., Gingi-Pak | 2022-01-10 |
| K213149 | VOCO Retraction Paste | Voco GmbH | 2021-12-09 |
| K200764 | STATSTIX | Centrix Incorporated | 2020-10-15 |
| K193389 | Vista Clear | Inter-Med/Vista Dental Products | 2020-03-04 |
| K190220 | Vista FS, Vista FS Liquid | Inter-Med/Vista Dental Products | 2019-06-10 |
| K171577 | Smartcord, Smartcord X | Eastdent Co., Ltd. | 2018-05-03 |
| K162662 | GingiDent Gingival Retraction Paste | Pac-Dent International, Inc. | 2017-10-20 |
| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials | Kerr Corporation | 2017-08-08 |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord | Kerr Corporation | 2017-02-03 |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord | Kerr Corporation | 2017-01-13 |
| K152064 | Astringedent Clear | Ultradent Products, Inc. | 2015-09-24 |
| K150423 | EXPAZEN | Produits Dentaires Pierre Rolland (Acteon Group) | 2015-07-08 |
| K130580 | RETRACTION PASTE | Dmg USA, Inc. | 2014-02-25 |
| K131799 | QUICKNIT | Microcopy, Div. of Neo-Flo, Inc. | 2014-01-16 |
| K132526 | KNIT-PAK+ | Premier Dental Products Co. | 2013-11-26 |
| K123215 | VISCOSTAT CLEAR | Ultradent Products, Inc. | 2013-02-05 |
| K113839 | RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE | Parkell, Inc. | 2012-04-12 |
| K111978 | SULCUS BLUE | Produits Dentaires Pierre Rolland | 2011-10-13 |
| K111348 | RE / STASIS (TM) GINGIVAL RETRACTION PASTE | Centrix, Inc. | 2011-07-22 |
| K101756 | TSC | Kerr Corporation | 2010-10-26 |
| K102133 | GIRAFFE2 | Kerr Corporation | 2010-10-07 |
| K093721 | COSP2 | 3M Espe AG Dental Products | 2010-02-19 |
| K093711 | RACEGEL | Septodont | 2010-02-17 |
| K092384 | LIQUICORD | Centrix, Inc. | 2009-11-04 |
| K091380 | CORDCAP | Centrix, Inc. | 2009-07-30 |
| K083695 | TRAXODENT | Premier Dental Products Co. | 2009-04-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| J014660872140 | Retraxil blue | Kulzer GmbH | 2026-04-21 |
| J014660872150 | Retraxil blue | Kulzer GmbH | 2026-04-21 |
| J014661012760 | Retraxil blue | Kulzer GmbH | 2026-04-21 |
| J014661012770 | Retraxil blue | Kulzer GmbH | 2026-04-21 |
| J014661012780 | Retraxil blue | Kulzer GmbH | 2026-04-21 |
| 10810000525710 | Simplee® | PARKELL, INC. | 2023-06-09 |
| 10810000527738 | Dryz™ | PARKELL, INC. | 2021-12-10 |
| 10810000525574 | Dryz™ | PARKELL, INC. | 2021-10-01 |
| 10304040151416 | HSEU | HENRY SCHEIN, INC. | 2021-04-02 |
| 10304040151447 | HSEU | HENRY SCHEIN, INC. | 2021-03-12 |
| 10304040151386 | HSEU | HENRY SCHEIN, INC. | 2021-03-12 |
| 10818207020526 | Quick Stat Liquid Bulk Syringe | Vista Dental | 2021-01-20 |
| 10818207020519 | Quick Stat Liquid 30mL bottle | Vista Dental | 2021-01-14 |
| H65890044541 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-24 |
| 10304040029470 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040029487 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| H658890044541 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040029463 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040029449 | Henry Schein | HENRY SCHEIN, INC. | 2020-04-21 |
| 10304040059446 | Henry Schein | HENRY SCHEIN, INC. | 2019-02-13 |
| 10304040025984 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| 10304040025960 | Henry Schein | HENRY SCHEIN, INC. | 2016-09-24 |
| J001702011441700 | Impregum™ Penta™ Soft Medium Body | 3M Deutschland GmbH | 2016-09-24 |
| J001702011373150 | 3M™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011373070 | 3M™ | 3M Deutschland GmbH | 2016-09-24 |
| J001702011372990 | 3M™ | 3M Deutschland GmbH | 2016-09-24 |
| 10841396117050 | Expasyl | KERR CORPORATION | 2016-08-31 |
| 10841396117067 | Expasyl | Kerr Corporation | 2016-08-31 |
| 10841396117111 | Expasyl | KERR CORPORATION | 2016-08-31 |
| 10841396117128 | Expasyl | KERR CORPORATION | 2016-08-31 |