Cleared Special

K040643 - BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES

K040643 is an FDA 510(k) clearance for BRANEMARK INTEGRATION DENTAL IMPLANT AN..., 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 27-day FDA review.

K040643 · Branemark Integration AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
27d
Days
Class 2
Risk

K040643 is an FDA 510(k) clearance for the BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES. 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 April 7, 2004 after a review of 27 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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 - K040643

510(k) Number K040643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2004
Decision Date April 07, 2004
Days to Decision 27 days
Submission Type Special
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
101d faster than avg
Panel avg: 128d · This submission: 27d
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 K040643.
LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
K033699 · Zest Anchors, Inc. · Apr 2004
MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK
K033630 · Rhein 83 Srl · Apr 2004
HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT
K040714 · Innova Corp. · Apr 2004
ZTI IMPLANTS SYSTEM, DRM IMPLANTS
K034067 · Drm Research Laboratories, Inc. · Mar 2004
SPI CONTACT DENTAL IMPLANT
K034014 · Thommen Medical AG · Mar 2004
SILHOUETTE(TM) IC OR SILHOUETTE(TM) & LASER-LOK (TM)
K032454 · Bio-Lok Intl., Inc. · Mar 2004
K040643 · BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES
Download PDF FDA Summary Branemark Integration…