The following data is part of a premarket notification filed by Miltex, Inc. with the FDA for Dental Instruments - Probes.
Device ID | K823324 |
510k Number | K823324 |
Device Name: | DENTAL INSTRUMENTS - PROBES |
Classification | Probe, Periodontic |
Applicant | MILTEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EIX |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-08 |
Decision Date | 1982-11-24 |