Cleared Traditional

K992330 - THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K992330 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 134-day FDA review.

K992330 · Biomedics · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
134d
Days
Class 2
Risk

K992330 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 November 23, 1999 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomedics devices

FDA 510(k) Submission Details - K992330

510(k) Number K992330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1999
Decision Date November 23, 1999
Days to Decision 134 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
7d slower than avg
Panel avg: 127d · This submission: 134d
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 K992330.
MODUS SAGITTAL SPLIT PLATE
K993862 · The Straumann Co. · Dec 1999
MODUS 2.5 MANDIBULAR RECONSTRUCTION SET
K992682 · Medartis AG · Nov 1999
MODUS 2.5 MANDIBULAR TRAUMA SET
K992683 · Medartis AG · Nov 1999
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
DRG TITANIUM BONE PLATE
K990920 · Doctor'S Research Group, Inc. · Jun 1999
NORMED BONE TRANSPORT
K990140 · Ace Surgical Supply Co., Inc. · Mar 1999