The following data is part of a premarket notification filed by Eare Consulting Service with the FDA for Dental Drill.
Device ID | K934981 |
510k Number | K934981 |
Device Name: | DENTAL DRILL |
Classification | Instrument, Diamond, Dental |
Applicant | EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
Contact | Emanuel A Rosen |
Correspondent | Emanuel A Rosen EARE CONSULTING SERVICE P.O. BOX 1309 Eilat, IL 88112 |
Product Code | DZP |
CFR Regulation Number | 872.4535 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-19 |
Decision Date | 1994-02-03 |