Cleared Traditional

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES

K854168 · Travenol Laboratories, S.A. · Dental

Mar 1986

Decision

149d

Days

Class 1

Risk

About This 510(k) Submission

K854168 is an FDA 510(k) clearance for the TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES, a Instrument, Hand, Calculus Removal (Class I — General Controls, product code ELA), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on March 13, 1986, 149 days after receiving the submission on October 15, 1985. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K854168 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 1985
Decision Date	March 13, 1986
Days to Decision	149 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—