Traxodent 9007086
by Premier Dental Products Company
Traxodent 9007086 is a gingival retraction solution (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Premier Dental Products Company, cleared under FDA 510(k) K083695 on 28 Apr 2009 and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 00348783000337), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00348783000337 | Date14 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK083695 | Date28 Apr 2009 | StatusActive |
Official records
- AccessGUDID record 00348783000337
- FDA 510(k) database K083695
Across registries
- FDA 510(k) K083695 decided 28 Apr 2009 Active
- FDA GUDID UDI-DI 00348783000337 listed 14 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K083695
- Listed FDA GUDID 00348783000337
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Traxodent
- Generic name
- Gingival retraction solution
- Model / reference
- 9007086
- Primary DI / UDI-DI
- 00348783000337
- 510(k) Number
- FDA product code
- MVL
- GMDN term
- Gingival retraction solution
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MVL (Cord, Retraction).
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- One-Stop by MEDICLUS Co., Ltd.
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- CyClean Cord by SS Global
- ViscoStat Clear S646 by ULTRADENT PRODUCTS, INC.