Massad MALC1Z3
Massad MALC1Z3 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 20 Sep 2018 (UDI-DI M482MALC1Z30), 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 | NumberM482MALC1Z30 | Date20 Sep 2018 | 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 M482MALC1Z30 listed 20 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K101029
- Listed FDA GUDID M482MALC1Z30
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Massad
- Generic name
- Resin artificial teeth
- Model / reference
- MALC1Z3
- Primary DI / UDI-DI
- M482MALC1Z30
- 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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- 25102 by Gebdi Dental-Products GmbH
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- CediTEC DT 6087 by VOCO GmbH
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- Condylaform II NFC by Ivoclar Vivadent, Inc.
- DENTURE PLASTIC TEETH, 76 ELM by Nobelpharma USA, Inc.