Cleared Traditional

TOOTH SLOOTH

K833338 · Joel Lander D.D.S. · Dental
Nov 1983
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K833338 is an FDA 510(k) clearance for the TOOTH SLOOTH, a Handle, Instrument, Dental (Class I — General Controls, product code EJB), submitted by Joel Lander D.D.S. (Walker, US). The FDA issued a Cleared decision on November 25, 1983, 59 days after receiving the submission on September 27, 1983. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K833338 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1983
Decision Date November 25, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJB — Handle, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565