Cleared Traditional

K071638 - BIOHORIZONS TAPERED INTERNAL IMPLANT SY...

K071638 is the FDA 510(k) clearance for BIOHORIZONS TAPERED INTERNAL IMPLANT SY... by BioHorizons Implant Systems, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K071638 · BioHorizons Implant Systems, Inc. · Dental device
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Oct 2007
Decision
117d
Days
Class 2
Risk

K071638 is an FDA 510(k) clearance for the BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on October 10, 2007 after a review of 117 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 K071638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2007
Decision Date October 10, 2007
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K071638.
NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
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K072896 · Osstem Implant Co., Ltd. · Nov 2007
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K072589 · Zimmer Dental, Inc. · Oct 2007
GS SYSTEM
K063861 · Osstem Implant Co., Ltd. · Sep 2007
ZIMMER PATIENT-SPECIFIC ABUTMENT, INTERNAL HEX, TITANIUM
K071439 · Zimmer Dental, Inc. · Sep 2007