Cleared Traditional

K891331 - UNI-STICK PLASTIC LIGATURES
(FDA 510(k) Clearance)

K891331 · American Orthodontics · Dental device

Oct 1989

Decision

220d

Days

Class 1

Risk

K891331 is an FDA 510(k) clearance for the UNI-STICK PLASTIC LIGATURES. 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 October 16, 1989, 220 days after receiving the submission on March 10, 1989.

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

Submission Details

510(k) Number	K891331 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 10, 1989
Decision Date	October 16, 1989
Days to Decision	220 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—