Cleared Traditional

CompleClear Plastic Orthodontic Bracket and Wire Appliance

K150830 · Oracrew · Dental

Aug 2016

Decision

515d

Days

Class 2

Risk

About This 510(k) Submission

K150830 is an FDA 510(k) clearance for the CompleClear Plastic Orthodontic Bracket and Wire Appliance, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Oracrew (Las Vegas, US). The FDA issued a Cleared decision on August 26, 2016, 515 days after receiving the submission on March 30, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K150830 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 30, 2015
Decision Date	August 26, 2016
Days to Decision	515 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF