Cleared Traditional

K980983 - THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY

K980983 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 84-day FDA review.

K980983 · Biomedics · Dental device
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Jun 1998
Decision
84d
Days
Class 2
Risk

K980983 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 June 9, 1998 after a review of 84 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 - K980983

510(k) Number K980983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1998
Decision Date June 09, 1998
Days to Decision 84 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
43d faster than avg
Panel avg: 127d · This submission: 84d
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 K980983.
ACE ALVEOLAR DISTRACTOR
K981526 · Ace Surgical Supply Co., Inc. · Nov 1998
BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM
K982139 · Bionx Implants, Inc. · Sep 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · Synthes (Usa) · Aug 1998
LACTOSORB PANELS AND FASTENERS
K980927 · Biomet, Inc. · Jun 1998
20-HOLE ADAPTATION PLATE
K981070 · Biomet, Inc. · May 1998
LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREW
K980512 · Walter Lorenz Surgical, Inc. · May 1998