Cleared Traditional

K972463 - THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K972463 is an FDA 510(k) clearance for THE BIOPLATE RIGID FIXATION BONE PLATIN..., manufactured by Biomedics. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972463 · Biomedics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
86d
Days
Class 2
Risk

K972463 is an FDA 510(k) clearance for the THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomedics (Los Angeles, US). The FDA issued a Cleared decision on September 25, 1997 after a review of 86 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomedics devices

FDA 510(k) Submission Details - K972463

510(k) Number K972463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1997
Decision Date September 25, 1997
Days to Decision 86 days
Submission Type Traditional
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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 237
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K972463.
SYNTHES RESORBABLE FIXATION SYSTEM
K974554 · Synthes (Usa) · Feb 1998
CHIN DISTRACTOR
K973484 · Howmedica, Inc. · Dec 1997
TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM
K973145 · Sofamor Danek USA,Inc. · Nov 1997
LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATES
K972322 · Walter Lorenz Surgical, Inc. · Aug 1997
COHEN DISTRACTOR
K972154 · Howmedica Leibinger, Inc. · Aug 1997
GUERRERO - BELL DISTRACTOR
K972166 · Howmedica Leibinger, Inc. · Aug 1997