The following data is part of a premarket notification filed by Dentco, Inc. with the FDA for Easy Pneumatic Crown And Bridge Remover.
Device ID | K951299 |
510k Number | K951299 |
Device Name: | EASY PNEUMATIC CROWN AND BRIDGE REMOVER |
Classification | Remover, Crown |
Applicant | DENTCO, INC. 5 FRANKLIN AVE. White Plains, NY 10601 |
Contact | Patrick J Lamb |
Correspondent | Patrick J Lamb DENTCO, INC. 5 FRANKLIN AVE. White Plains, NY 10601 |
Product Code | EIS |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-22 |
Decision Date | 1995-08-29 |