ApexPaste Hard APEX-H
ApexPaste Hard APEX-H is a Class II device made by Dsi Dental Solutions, Ltd., cleared under FDA 510(k) K212475 on 13 May 2022 and listed in FDA GUDID since 15 Feb 2023 (UDI-DI D95600APEXH0), active as of 22 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 | NumberD95600APEXH0 | Date15 Feb 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK212475 | Date13 May 2022 | StatusActive |
Official records
- FDA 510(k) database K212475
Across registries
- FDA 510(k) K212475 decided 13 May 2022 Active
- FDA GUDID UDI-DI D95600APEXH0 listed 15 Feb 2023 Listed
Timeline
- Cleared FDA 510(k) K212475
- Listed FDA GUDID D95600APEXH0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ApexPaste Hard
- Generic name
- Calcium hydroxide dental cement
- Model / reference
- APEX-H
- Primary DI / UDI-DI
- D95600APEXH0
- 510(k) Number
- FDA product code
- EJK
- GMDN term
- Calcium hydroxide dental cement
- Device class
- Class II
- Regulation number
- 872.3250
- GUDID distribution status
- In Commercial Distribution
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