Cleared Traditional

K900488 - MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE
(FDA 510(k) Clearance)

K900488 · American Orthodontics · Dental

Jun 1990

Decision

122d

Days

Class 1

Risk

K900488 is an FDA 510(k) clearance for the MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on June 1, 1990, 122 days after receiving the submission on January 30, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K900488 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 30, 1990
Decision Date	June 01, 1990
Days to Decision	122 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—