The following data is part of a premarket notification filed by Cmp Industries Llc. with the FDA for Polystar 79 Denture Base Resin.
Device ID | K072851 |
510k Number | K072851 |
Device Name: | POLYSTAR 79 DENTURE BASE RESIN |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | CMP INDUSTRIES LLC. 413 NORTH PEARL ST. Albany, NY 12207 |
Contact | Devon O Howe |
Correspondent | Devon O Howe CMP INDUSTRIES LLC. 413 NORTH 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 | 2007-10-04 |
Decision Date | 2008-02-20 |