Cleared Traditional

K843705 - MANDIBULATOR JAW POSITIONER
(FDA 510(k) Clearance)

K843705 · A Company, Inc. · Dental
Nov 1984
Decision
54d
Days
Class 1
Risk

K843705 is an FDA 510(k) clearance for the MANDIBULATOR JAW POSITIONER, a Retainer, Screw Expansion, Orthodontic (Class I — General Controls, product code DYJ), submitted by A Company, Inc. (San Diego, US). The FDA issued a Cleared decision on November 14, 1984, 54 days after receiving the submission on September 21, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K843705 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 1984
Decision Date November 14, 1984
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DYJ — Retainer, Screw Expansion, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410