Cleared Traditional

K040650 - BONAMATES SERIES

K040650 is an FDA 510(k) clearance for BONAMATES SERIES, manufactured by Biotech One, 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.

K040650 · Biotech One, Inc. · Dental device
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Jun 2004
Decision
84d
Days
Class 2
Risk

K040650 is an FDA 510(k) clearance for the BONAMATES SERIES. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biotech One, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on June 3, 2004 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 Biotech One, Inc. devices

FDA 510(k) Submission Details - K040650

510(k) Number K040650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2004
Decision Date June 03, 2004
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
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 241
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K040650.
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LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · Walter Lorenz Surgical, Inc. · May 2004
SYNTHES (USA) CRANIOFACIAL PLATES
K040272 · Synthes (Usa) · Feb 2004
INION CPS BABY 1.5 BIOABSORBABLE SYSTEM
K033194 · Inion , Ltd. · Oct 2003