Nobilplast Denture Resin
510(k) K170375
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK170375 | Date2 Oct 2017 | StatusActive |
Official records
- FDA 510(k) database K170375
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EBI
- FDA applicant
- Cmp Industries, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Nobilplast Denture Resin is a resin used for the fabrication of partial or full removable dentures, as well as occlusal applications. It is classified as a denture relining, repairing, or rebasing resin under product code EBI.
This device is supplied as a Class II medical device with special controls and received FDA 510(k) clearance on October 2, 2017. It is manufactured by CMP Industries LLC in Albany, New York, and is intended for dental applications requiring denture fabrication or repair.