The following data is part of a premarket notification filed by Cmp Industries Llc with the FDA for Nobilplast Denture Resin.
Device ID | K170375 |
510k Number | K170375 |
Device Name: | Nobilplast Denture Resin |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | CMP Industries LLC 413 N. Pearl St. Albany, NY 12207 |
Contact | Devon O. Howe |
Correspondent | Devon O. Howe CMP Industries LLC 413 N. Pearl St. Albany, NY 12207 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-07 |
Decision Date | 2017-10-02 |
Summary: | summary |