EsBond S2 101-5007
EsBond S2 101-5007 is a dental composite resin (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Spident Co., Ltd., cleared under FDA 510(k) K092572 on 26 Aug 2009 and listed in FDA GUDID since 21 Aug 2018 (UDI-DI 08809262959956), 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 | Number08809262959956 | Date21 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092572 | Date26 Aug 2009 | StatusActive |
Official records
- AccessGUDID record 08809262959956
- FDA 510(k) database K092572
Across registries
- FDA 510(k) K092572 decided 26 Aug 2009 Active
- FDA GUDID UDI-DI 08809262959956 listed 21 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K092572
- Listed FDA GUDID 08809262959956
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EsBond S2
- Generic name
- Dental composite resin
- Model / Ref / Catalog
- 101-5007
- Primary DI / UDI-DI
- 08809262959956
- 510(k) Number
- FDA product code
- EBF
- GMDN term
- Dental composite resin
- Device class
- Class II
- Regulation number
- 872.3690
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental composite resin.
- dline Light Curing Temporary Filling Material 19300 by UAB "Medicinos linija"
- Polofil Supra N 1410 by VOCO GmbH
- T Com Flow FP1026B1 by NEXOBIO CO., LTD.
- DiaFil Flow Economic Package C2 A2001-4107 by DiaDent Group International
- Meron Dental Cement by VOCO GmbH
- Simile N56BH by KERR CORPORATION
- DenFil DF104-RC22 by VERICOM CO., LTD.
- Prime-Dent Visible Light Cure Micro Hybrid Composite 001-414 by Prime Dental Manufacturing
- SYNERGY 7831 by Coltène/Whaledent AG
- SYNERGY D6 8384 by Coltène/Whaledent AG