Cleared Special

K132600 - FACIAL PREBENT PLATING WITH VIRTUAL SUR...

K132600 is an FDA 510(k) clearance for FACIAL PREBENT PLATING WITH VIRTUAL SUR..., manufactured by Biomet Microfixation. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 43-day FDA review.

K132600 · Biomet Microfixation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2013
Decision
43d
Days
Class 2
Risk

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

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on October 2, 2013 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomet Microfixation devices

FDA 510(k) Submission Details - K132600

510(k) Number K132600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 127d · This submission: 43d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K132600.
RXG DISTRACTION SYSTEM
K133304 · KLS-Martin L.P. · May 2014
LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM
K121235 · Stryker · Jan 2014
STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT
K132519 · Stryker · Dec 2013
I-GEN
K131289 · Megagen Implant Co., Ltd. · Sep 2013
SMARTBUILDER SYSTEM (SB1)
K130840 · Osstem Implant Co., Ltd. · Sep 2013
PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING
K131674 · Biomet Microfixation · Aug 2013