Massad MALC4L6
Massad MALC4L6 is a device of GMDN type resin artificial teeth (FDA Class II; FDA product code ELM, Denture, Plastic, Teeth) made by Cmp Industries LLC, cleared under FDA 510(k) K101029 on 16 Aug 2010 and listed in FDA GUDID since 7 Sep 2017 (UDI-DI M482MALC4L60), 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 | NumberM482MALC4L60 | Date7 Sep 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK101029 | Date16 Aug 2010 | StatusActive |
Official records
- FDA 510(k) database K101029
Across registries
- FDA 510(k) K101029 decided 16 Aug 2010 Active
- FDA GUDID UDI-DI M482MALC4L60 listed 7 Sep 2017 Listed
Timeline
- Cleared FDA 510(k) K101029
- Listed FDA GUDID M482MALC4L60
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Massad
- Generic name
- Resin artificial teeth
- Model / reference
- MALC4L6
- Primary DI / UDI-DI
- M482MALC4L60
- 510(k) Number
- FDA product code
- ELM
- GMDN term
- Resin artificial teeth
- Device class
- Class II
- Regulation number
- 872.3590
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ELM (Denture, Plastic, Teeth).
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- BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P by bredent GmbH & Co. KG
- ANTERIORS AND POSTERIORS, PLASTIC by Dentsply Intl.
- KORVIN VITA RADIOPAQUE PLASTIC TEETH by Credent Co.