GuttaSil 9387
GuttaSil 9387, a hygroscopic dental cement (FDA Class I) made by Meta Biomed Co., Ltd., was cleared under FDA 510(k) K190510 on 29 May 2019 and listed in FDA GUDID on 24 Jun 2019 (UDI-DI 08806387893875); the registry lists it as not in commercial distribution (GUDID) as of 12 Nov 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 | Number08806387893875 | Date24 Jun 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190510 | Date29 May 2019 | StatusActive |
Official records
- AccessGUDID record 08806387893875
- FDA 510(k) database K190510
Across registries
- FDA 510(k) K190510 decided 29 May 2019 Active
- FDA GUDID UDI-DI 08806387893875 listed 24 Jun 2019 Listed
Timeline
- Cleared FDA 510(k) K190510
- Listed FDA GUDID 08806387893875
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- GuttaSil
- Generic name
- Hygroscopic dental cement
- Model / reference
- 9387
- Primary DI / UDI-DI
- 08806387893875
- 510(k) Number
- FDA product code
- EKM, KIF
- GMDN term
- Hygroscopic dental cement
- Device class
- Class I
- Regulation number
- 872.3850, 872.3820
- GUDID distribution status
- Not in Commercial Distribution
Similar devices
Other devices filed under FDA product code EKM (Gutta-Percha).
- MM MARKED GUTTA PERCHA POINTS ISO 40 ML156-408 by DiaDent Group International
- MM MARKED GUTTA PERCHA POINTS DIA-PROISO-.04 PLUS 40 ML158-808 by DiaDent Group International
- GUTTA PERCHA POINTS by North Pacific Dental, Inc.
- HEATED GUTTA PERCHA DELIVERY SYSTEM by Unitek Corp.
- THERMAPREP by TULSA DENTAL PRODUCTS LLC
- THERMAPREP PLUS OVEN by TULSA DENTAL PRODUCTS LLC
- FIBERFILL SGP by Pentron Clinical Technologies