Cleared Special

K132600 - FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
(FDA 510(k) Clearance)

K132600 · Biomet Microfixation · Dental

Oct 2013

Decision

43d

Days

Class 2

Risk

K132600 is an FDA 510(k) clearance for the FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING. This device is classified as a Plate, Bone (Class II — Special Controls, product code JEY).

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on October 2, 2013, 43 days after receiving the submission on August 20, 2013.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K132600 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2013
Decision Date	October 02, 2013
Days to Decision	43 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF