Cleared Traditional

WILEY/ESPOSITO DENTAL GUARD

K935713 · Fvtnks · Anesthesiology
Jan 1994
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K935713 is an FDA 510(k) clearance for the WILEY/ESPOSITO DENTAL GUARD, a Protector, Dental (Class I — General Controls, product code BRW), submitted by Fvtnks (Indianapolis, US). The FDA issued a Cleared decision on January 5, 1994, 36 days after receiving the submission on November 30, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5820.

Submission Details

510(k) Number K935713 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1993
Decision Date January 05, 1994
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code BRW — Protector, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5820