Cleared Special

K090005 - BRANEMARK INTEGRATION BIOHELIX IMPLANTS

K090005 is an FDA 510(k) clearance for BRANEMARK INTEGRATION BIOHELIX IMPLANTS, manufactured by Branemark Integration AB. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 137-day FDA review.

K090005 · Branemark Integration AB · Dental device
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May 2009
Decision
137d
Days
Class 2
Risk

K090005 is an FDA 510(k) clearance for the BRANEMARK INTEGRATION BIOHELIX IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Branemark Integration AB (Goteborg, SE). The FDA issued a Cleared decision on May 19, 2009 after a review of 137 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K090005

510(k) Number K090005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 2009
Decision Date May 19, 2009
Days to Decision 137 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 128d · This submission: 137d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K090005.
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SPECTRA SYSTEM DENTAL IMPLANTS 2008
K090234 · Implant Direct, LLC · May 2009
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K083633 · Osstem Implant Co., Ltd. · May 2009
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K083586 · Dentis Co., Ltd. · Apr 2009
K090005 · BRANEMARK INTEGRATION BIOHELIX IMPLANTS
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