Cleared Traditional

PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX

K781035 · Premier Dental Products Co. · Dental
Jun 1978
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K781035 is an FDA 510(k) clearance for the PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX, a Scaler, Periodontic (Class I — General Controls, product code EMN), submitted by Premier Dental Products Co. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978, 11 days after receiving the submission on June 19, 1978. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K781035 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1978
Decision Date June 30, 1978
Days to Decision 11 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EMN — Scaler, Periodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565