The following data is part of a premarket notification filed by Adp Intl., Inc. with the FDA for Endodontic Instruments.
Device ID | K760983 |
510k Number | K760983 |
Device Name: | ENDODONTIC INSTRUMENTS |
Classification | Point, Paper, Endodontic |
Applicant | ADP INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EKN |
CFR Regulation Number | 872.3830 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-10-21 |
Decision Date | 1976-11-15 |