Cleared Traditional

K953273 - BIOPLATE RIGID FIXATION BONE PLATING SYSTEM

K953273 is an FDA 510(k) clearance for BIOPLATE RIGID FIXATION BONE PLATING SYSTEM, manufactured by Biomedics. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K953273 · Biomedics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
78d
Days
Class 2
Risk

K953273 is an FDA 510(k) clearance for the BIOPLATE RIGID FIXATION BONE PLATING SYSTEM. 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 29, 1995 after a review of 78 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 - K953273

510(k) Number K953273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date September 29, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 127d · This submission: 78d
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 239
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K953273.
3I OSSEOUS FIXATION SYSTEM(S)
K960914 · Implant Innovations, Inc. · Apr 1996
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · Synthes (Usa) · Mar 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
K953385 · Walter Lorenz Surgical, Inc. · Sep 1995
9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS
K953386 · Implant Innovations, Inc. · Sep 1995
3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
K952811 · Implant Innovations, Inc. · Aug 1995