Alpha-Dent Core Buildup Paste
by Alpha-Dent
510(k) K932827
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Overview
Alpha-Dent Core Buildup Paste is a dental material designed for use in filling teeth. It's an effective solution for repairing cavities and restoring damaged tooth structure.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932827 | Date23 Sep 1993 | StatusActive |
Official records
- FDA 510(k) database K932827
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBF
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3690
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K932827
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Alpha-Core® SC 120.0025.002 | 120.0025.002 / 120.0025.002 | D73512000250020 | — | On the market |
| Alpha-Core® SC 120.0026.002 | 120.0026.002 / 120.0026.002 | D73512000260020 | — | On the market |
| Alpha-Core® SC 120.0027.002 | 120.0027.002 / 120.0027.002 | D73512000270020 | — | On the market |
| Alpha-Core® SC 120.0602.002 | 120.0602.002 / 120.0602.002 | D73512006020020 | — | On the market |
| Alpha-Core® SC 120.0703.002 | 120.0703.002 / 120.0703.002 | D73512007030020 | — | On the market |
| Alpha-Core® SC 120.0803.002 | 120.0803.002 / 120.0803.002 | D73512008030020 | — | On the market |
| Alpha-Core® SC 120.0903.002 | 120.0903.002 / 120.0903.002 | D73512009030020 | — | On the market |
| Premier 3001401 | 3001401 | D6913001401 | — | On the market |
| Premier 3001402 | 3001402 | D6913001402 | — | On the market |
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