The following data is part of a premarket notification filed by Alvin Meyer, D.d.s. with the FDA for Palodent Matrices & Bitine Rings.
Device ID | K801142 |
510k Number | K801142 |
Device Name: | PALODENT MATRICES & BITINE RINGS |
Classification | Instruments, Dental Hand |
Applicant | ALVIN MEYER, D.D.S. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DZN |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-13 |
Decision Date | 1980-08-07 |