Traxodent
by Premier Dental Products Company
510(k) K083695
Traxodent is a medical device (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Premier Dental Products Company, cleared under FDA 510(k) K083695 on 28 Apr 2009, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK083695 | Date28 Apr 2009 | StatusActive |
Official records
- FDA 510(k) database K083695
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MVL
- FDA applicant
- Premier Dental Products Co.
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K083695
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Traxodent - Itena TRABOI-7 | 7007093 / TRABOI-7 | 00348783001013 | On the market | |
| Traxodent - Itena TRAPACK-25 | 7007091 / TRAPACK-25 | 00348783001006 | On the market | |
| Traxodent - Itena TRASTRT-2 | 7007097 / TRASTRT-2 | 00348783001020 | On the market | |
| Traxodent 900-7093 | 900-7093 | 00348783000290 | On the market | |
| Traxodent 9007086 | 9007086 | 00348783000337 | On the market | |
| Traxodent 9007090 | 9007090 | 00348783013283 | On the market | |
| Traxodent 9007091 | 9007091 | 00348783000269 | On the market | |
| Traxodent 9007093 | 9007093 | 00348783000276 | On the market | |
| Traxodent 9007094 | 9007094 | 00348783000306 | On the market | |
| Traxodent 9007095 | 9007095 | 00348783000313 | On the market | |
| Traxodent 9007097 | 9007097 | 00348783000283 | On the market | |
| Traxodent 9007098 | 9007098 | 00348783000320 | On the market |
Similar devices
Other devices filed under FDA product code MVL (Cord, Retraction).
- GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord by KERR CORPORATION
- HEMOSTASYL PASTE by Satelec
- RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE by PARKELL, INC.
- Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/Materials by KERR CORPORATION
- One-Stop by MEDICLUS Co., Ltd.
- Retrax Solution 15 mL 15600 by PASCAL COMPANY, INC.
- CyClean Cord by SS Global
- ViscoStat Clear S646 by ULTRADENT PRODUCTS, INC.
- COSP2 by 3M Espe AG Dental Products
- EXPAZEN by Produits Dentaires Pierre Rolland (Acteon Group)