Cleared Special

K131674 - PREBENT PLATING WITH VIRTUAL SURGICAL P...

K131674 is an FDA 510(k) clearance for PREBENT PLATING WITH VIRTUAL SURGICAL P..., 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 62-day FDA review.

K131674 · Biomet Microfixation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
62d
Days
Class 2
Risk

K131674 is an FDA 510(k) clearance for the 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 August 8, 2013 after a review of 62 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 - K131674

510(k) Number K131674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 127d · This submission: 62d
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 K131674.
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K120951 · Osstem Implant Co., Ltd. · Oct 2012