Cleared Traditional

MOLAR DISTALIZING ASSEMBLY

K912417 · American Orthodontics · Dental
Dec 1991
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K912417 is an FDA 510(k) clearance for the MOLAR DISTALIZING ASSEMBLY, a Retainer, Screw Expansion, Orthodontic (Class I — General Controls, product code DYJ), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on December 20, 1991, 203 days after receiving the submission on May 31, 1991. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K912417 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1991
Decision Date December 20, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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