Cleared Traditional

K990920 - DRG TITANIUM BONE PLATE

K990920 is an FDA 510(k) clearance for DRG TITANIUM BONE PLATE, manufactured by Doctor'S Research Group, Inc.. 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.

K990920 · Doctor'S Research Group, Inc. · Dental device
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Jun 1999
Decision
84d
Days
Class 2
Risk

K990920 is an FDA 510(k) clearance for the DRG TITANIUM BONE PLATE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Doctor'S Research Group, Inc. (Wolcott, US). The FDA issued a Cleared decision on June 10, 1999 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 Doctor'S Research Group, Inc. devices

FDA 510(k) Submission Details - K990920

510(k) Number K990920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1999
Decision Date June 10, 1999
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 K990920.
MODUS 2.5 MANDIBULAR TRAUMA SET
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THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K992330 · Biomedics · Nov 1999
LACTOSORB SHEETS
K992158 · Biomet, Inc. · Aug 1999
NORMED BONE TRANSPORT
K990140 · Ace Surgical Supply Co., Inc. · Mar 1999
MACROPORE PROTECTIVE SHEET
K983360 · Pacific Materials and Interfaces · Mar 1999
BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM
K982721 · Bionx Implants, Inc. · Feb 1999