Cleared Traditional

K961976 - THE BIOPLATE FIXATION SYSTEM

K961976 is an FDA 510(k) clearance for THE BIOPLATE FIXATION 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 88-day FDA review.

K961976 · Biomedics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
88d
Days
Class 2
Risk

K961976 is an FDA 510(k) clearance for the THE BIOPLATE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomedics (Washington, US). The FDA issued a Cleared decision on August 16, 1996 after a review of 88 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 - K961976

510(k) Number K961976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date August 16, 1996
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 K961976.
VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE
K964649 · Howmedica Leibinger, Inc. · Jan 1997
SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE
K964328 · Synthes (Usa) · Dec 1996
OSTEOMED TRAM
K963394 · Osteomed Corp. · Nov 1996
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
K961421 · Synthes (Usa) · Jun 1996
TMP MANDIBULAR COMPRESSION SYSTEM (MODIFICATION)
K960514 · Anspach Fixation Systems · Apr 1996
3I OSSEOUS FIXATION SYSTEM(S)
K960914 · Implant Innovations, Inc. · Apr 1996