Cleared Traditional

K093299 - SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM (FDA 510(k) Clearance)

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

K093299 · Synthes (Usa) · Dental device
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Dec 2010
Decision
421d
Days
Class 2
Risk

K093299 is an FDA 510(k) clearance for the SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on December 16, 2010 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Synthes (Usa) devices

Submission Details

510(k) Number K093299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2009
Decision Date December 16, 2010
Days to Decision 421 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
294d slower than avg
Panel avg: 127d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
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.