Cleared Traditional

BIOHORIZONS ABUTMENTS FOR ZIMMER (K103691) - FDA 510(k) Clearance

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

K103691 · BioHorizons Implant Systems, Inc. · Dental device
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Nov 2011
Decision
321d
Days
Class 2
Risk

K103691 is an FDA 510(k) clearance for the BIOHORIZONS ABUTMENTS FOR ZIMMER. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on November 3, 2011 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 BioHorizons Implant Systems, Inc. devices

Submission Details

510(k) Number K103691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2010
Decision Date November 03, 2011
Days to Decision 321 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
194d slower than avg
Panel avg: 127d · This submission: 321d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 705
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