Cleared Traditional

K893484 - MULTIPHASE ORTHODONTIC WIRE
(FDA 510(k) Clearance)

K893484 · American Orthodontics · Dental device

Jul 1989

Decision

71d

Days

Class 1

Risk

K893484 is an FDA 510(k) clearance for the MULTIPHASE ORTHODONTIC WIRE. This device is classified as a Bracket, Metal, Orthodontic (Class I - General Controls, product code EJF).

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on July 14, 1989, 71 days after receiving the submission on May 4, 1989.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K893484 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 04, 1989
Decision Date	July 14, 1989
Days to Decision	71 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—