Henry Schein 5702993
Henry Schein 5702993 is a dental amalgam well (FDA Class II; FDA product code ELW, Material, Impression) made by Henry Schein, Inc., cleared under FDA 510(k) K040053 on 25 Mar 2004 and listed in FDA GUDID since 8 Apr 2022 (UDI-DI 00304040163009), 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 | Number00304040163009 | Date8 Apr 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK040053 | Date25 Mar 2004 | StatusActive |
Official records
- AccessGUDID record 00304040163009
- FDA 510(k) database K040053
Across registries
- FDA 510(k) K040053 decided 25 Mar 2004 Active
- FDA GUDID UDI-DI 00304040163009 listed 8 Apr 2022 Listed
Timeline
- Cleared FDA 510(k) K040053
- Listed FDA GUDID 00304040163009
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Henry Schein
- Generic name
- Dental amalgam well
- Model / Ref / Catalog
- 5702993
- Primary DI / UDI-DI
- 00304040163009
- 510(k) Number
- FDA product code
- ELW
- GMDN term
- Dental amalgam well
- Device class
- Class II
- Regulation number
- 872.3660
- GUDID distribution status
- In Commercial Distribution
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- ELITE FAST LIGHT BODY by Zhermack Dental Production
- SEPTOSIL SILICONE FOR PRECISION IMPRESSION by Specialites Septodont
- REVERSIBLE HYDROCOLLOID IMPRESSION by Kottler Laboratories
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- HYDROFLEX by Gc America Inc.