Cleared Traditional

TIP TOLEDO INCISOR PROTECTOR

K851640 · Edward O. Goodwich · Anesthesiology
Sep 1985
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K851640 is an FDA 510(k) clearance for the TIP TOLEDO INCISOR PROTECTOR, a Protector, Dental (Class I — General Controls, product code BRW), submitted by Edward O. Goodwich (Narberth, US). The FDA issued a Cleared decision on September 18, 1985, 160 days after receiving the submission on April 11, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5820.

Submission Details

510(k) Number K851640 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 1985
Decision Date September 18, 1985
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

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