Sure-endo SCP-000
Sure-endo SCP-000 is a gingival retraction cord (FDA unclassified; FDA product code MVL, Cord, Retraction) made by Sure Dent Corporation, cleared under FDA 510(k) K132526 on 26 Nov 2013 and listed in FDA GUDID since 10 Apr 2020 (UDI-DI 08809264299944), 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 | Number08809264299944 | Date10 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132526 | Date26 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 08809264299944
- FDA 510(k) database K132526
Across registries
- FDA 510(k) K132526 decided 26 Nov 2013 Active
- FDA GUDID UDI-DI 08809264299944 listed 10 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K132526
- Listed FDA GUDID 08809264299944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sure-endo
- Generic name
- Gingival retraction cord, medicated
- Model / reference
- SCP-000
- Primary DI / UDI-DI
- 08809264299944
- 510(k) Number
- FDA product code
- MVL
- GMDN term
- Gingival retraction cord, medicated
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
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