Nobilium I8191
Nobilium I8191 is a dental appliance fabrication material (FDA Class II; FDA product code EBI, Resin, Denture, Relining, Repairing, Rebasing) made by Cmp Industries LLC, cleared under FDA 510(k) K033020 on 19 Dec 2003 and listed in FDA GUDID since 17 Nov 2016 (UDI-DI M482I81910), active as of 23 Oct 2026. 4 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM482I81910 | Date17 Nov 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK033020 | Date19 Dec 2003 | StatusActive |
Official records
- FDA 510(k) database K033020
Across registries
- FDA 510(k) K033020 decided 19 Dec 2003 Active
- FDA GUDID UDI-DI M482I81910 listed 17 Nov 2016 Listed
Recalls
-
- Terminated Z-2098-2016
- Terminated Z-2097-2016
- Terminated Z-2089-2016
Possible presence of foreign material (rust).
-
- Terminated Z-1089-2016
During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.
Timeline
- Cleared FDA 510(k) K033020
- Recall initiated FDA recalls Z-1089-2016
- Recall initiated FDA recalls Z-2089-2016
- Recall initiated FDA recalls Z-2098-2016
- Recall initiated FDA recalls Z-2097-2016
- Listed FDA GUDID M482I81910
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Nobilium
- Generic name
- Dental appliance fabrication material, resin
- Model / reference
- I8191
- Primary DI / UDI-DI
- M482I81910
- 510(k) Number
- FDA product code
- EBI
- GMDN term
- Dental appliance fabrication material, resin
- Device class
- Class II
- Regulation number
- 872.3760
- GUDID distribution status
- In Commercial Distribution
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