Cleared Traditional

MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM (K073307) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K073307 · Bio-Technology USA, Inc. · Dental device
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Oct 2008
Decision
341d
Days
Class 2
Risk

K073307 is an FDA 510(k) clearance for the MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bio-Technology USA, Inc. (Austin, US). The FDA issued a Cleared decision on October 29, 2008 after a review of 341 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Bio-Technology USA, Inc. devices

Submission Details

510(k) Number K073307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2007
Decision Date October 29, 2008
Days to Decision 341 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 127d · This submission: 341d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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