The following data is part of a premarket notification filed by Cmp Industries Llc. with the FDA for Flexor (denture Acrylic Reline Material).
Device ID | K902972 |
510k Number | K902972 |
Device Name: | FLEXOR (DENTURE ACRYLIC RELINE MATERIAL) |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | CMP INDUSTRIES LLC. P.O. BOX 350 Albany, NY 12201 |
Contact | William Regan |
Correspondent | William Regan CMP INDUSTRIES LLC. P.O. BOX 350 Albany, NY 12201 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-07-06 |
Decision Date | 1990-10-04 |