Cleared Traditional

K012910 - THE BIOPLATE MANDIBLE FIXATION SYSTEM

K012910 is an FDA 510(k) clearance for THE BIOPLATE MANDIBLE FIXATION SYSTEM, manufactured by Bioplate, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K012910 · Bioplate, Inc. · Dental device
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Nov 2001
Decision
82d
Days
Class 2
Risk

K012910 is an FDA 510(k) clearance for the THE BIOPLATE MANDIBLE FIXATION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bioplate, Inc. (Washington, US). The FDA issued a Cleared decision on November 20, 2001 after a review of 82 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 Bioplate, Inc. devices

FDA 510(k) Submission Details - K012910

510(k) Number K012910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2001
Decision Date November 20, 2001
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
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 193
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K012910.
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · Stryker Instruments · Mar 2002
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002
THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K013055 · Bioplate, Inc. · Dec 2001
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · Inion , Ltd. · Oct 2001
STRAUMANN GBR SYSTEM
K011698 · Institut Straumann AG · Aug 2001
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001