Cleared Traditional

K855030 - CHAMPY BONE PLATES & BONE SCREWS

K855030 is an FDA 510(k) clearance for CHAMPY BONE PLATES & BONE SCREWS, manufactured by Advanced Biosearch Assn.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K855030 · Advanced Biosearch Assn. · Dental device
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Jan 1986
Decision
45d
Days
Class 2
Risk

K855030 is an FDA 510(k) clearance for the CHAMPY BONE PLATES & BONE SCREWS. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Advanced Biosearch Assn. (Rockville, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 45 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 Advanced Biosearch Assn. devices

FDA 510(k) Submission Details - K855030

510(k) Number K855030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date January 30, 1986
Days to Decision 45 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 127d · This submission: 45d
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 194
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K855030.
MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE
K862533 · Walter Lorenz Surgical, Inc. · Aug 1986
STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS
K862482 · Walter Lorenz Surgical, Inc. · Jul 1986
ACROMED NESTED BONE PLATE
K855224 · Buckman Co., Inc. · Feb 1986
WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
K854886 · Walter Lorenz Surgical, Inc. · Jan 1986
CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD
K840955 · Synthes (Usa) · Jun 1984