Cleared Traditional

K902064 - MODIFIED UNI-STICK PLASTIC LIGATURE
(FDA 510(k) Clearance)

K902064 · American Orthodontics · Dental device

Aug 1990

Decision

90d

Days

Class 1

Risk

K902064 is an FDA 510(k) clearance for the MODIFIED UNI-STICK PLASTIC LIGATURE. 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 August 6, 1990, 90 days after receiving the submission on May 8, 1990.

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

Submission Details

510(k) Number	K902064 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 08, 1990
Decision Date	August 06, 1990
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—