Cleared Traditional

K861965 - UNITEK CERAMIC BRACKET SYSTEM
(FDA 510(k) Clearance)

K861965 · Unitek Corp. · Dental

Jun 1986

Decision

21d

Days

Class 2

Risk

K861965 is an FDA 510(k) clearance for the UNITEK CERAMIC BRACKET SYSTEM. This device is classified as a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW).

Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on June 9, 1986, 21 days after receiving the submission on May 19, 1986.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K861965 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 1986
Decision Date	June 09, 1986
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—