Cleared Traditional

K760984 - ORTHODONTIC INSTRUMENTS
(FDA 510(k) Clearance)

Nov 1976
Decision
25d
Days
Class 1
Risk

K760984 is an FDA 510(k) clearance for the ORTHODONTIC INSTRUMENTS. This device is classified as a Plier, Orthodontic (Class I - General Controls, product code JEX).

Submitted by Adp Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on November 15, 1976, 25 days after receiving the submission on October 21, 1976.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K760984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1976
Decision Date November 15, 1976
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code JEX — Plier, Orthodontic
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4565