Cleared Special

K131674 - PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
(FDA 510(k) Clearance)

K131674 · Biomet Microfixation · Dental

Aug 2013

Decision

62d

Days

Class 2

Risk

K131674 is an FDA 510(k) clearance for the 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 August 8, 2013, 62 days after receiving the submission on June 7, 2013.

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

Submission Details

510(k) Number	K131674 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2013
Decision Date	August 08, 2013
Days to Decision	62 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF