Cleared Traditional

ROTARY SCALER

K782007 · Star Dental Mfg. Co. · Dental
Jan 1979
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K782007 is an FDA 510(k) clearance for the ROTARY SCALER, a Scaler, Rotary (Class II — Special Controls, product code ELB), submitted by Star Dental Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1979, 33 days after receiving the submission on December 1, 1978. This device falls under the Dental review panel. Regulated under 21 CFR 872.4840.

Submission Details

510(k) Number K782007 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1978
Decision Date January 03, 1979
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ELB — Scaler, Rotary
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4840