Cleared Traditional

DENTAL DRILL

K934981 · Eare Consulting Service · Dental
Feb 1994
Decision
107d
Days
Class 1
Risk

About This 510(k) Submission

K934981 is an FDA 510(k) clearance for the DENTAL DRILL, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on February 3, 1994, 107 days after receiving the submission on October 19, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number K934981 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1993
Decision Date February 03, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code DZP — Instrument, Diamond, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4535

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