Sure-endo SCP-0
Sure-endo SCP-0 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 08809264299968), 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 | Number08809264299968 | Date10 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK132526 | Date26 Nov 2013 | StatusActive |
Official records
- AccessGUDID record 08809264299968
- FDA 510(k) database K132526
Across registries
- FDA 510(k) K132526 decided 26 Nov 2013 Active
- FDA GUDID UDI-DI 08809264299968 listed 10 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K132526
- Listed FDA GUDID 08809264299968
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- Withdrawn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-0
- Primary DI / UDI-DI
- 08809264299968
- 510(k) Number
- FDA product code
- MVL
- GMDN term
- Gingival retraction cord, medicated
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MVL (Cord, Retraction).
- Retraxil by Kulzer, Inc.
- KORLEX-GR GINGIVAL RETRACTION PASTE by Biotech One, Inc.
- 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.