Cleared Traditional

ORTHOTECH DURA-GOLD BARCKETS

K933080 · Orthotech · Dental

Mar 1994

Decision

273d

Days

Class 1

Risk

About This 510(k) Submission

K933080 is an FDA 510(k) clearance for the ORTHOTECH DURA-GOLD BARCKETS, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Orthotech (Tampa, US). The FDA issued a Cleared decision on March 23, 1994, 273 days after receiving the submission on June 23, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number	K933080 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 1993
Decision Date	March 23, 1994
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement