Cleared Traditional

K083205 - NOBELACTIVE 8.5 MM & 18.0 MM

K083205 is an FDA 510(k) clearance for NOBELACTIVE 8.5 MM & 18.0 MM, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K083205 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
106d
Days
Class 2
Risk

K083205 is an FDA 510(k) clearance for the NOBELACTIVE 8.5 MM & 18.0 MM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on February 13, 2009 after a review of 106 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 Nobel Biocare AB devices

FDA 510(k) Submission Details - K083205

510(k) Number K083205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2008
Decision Date February 13, 2009
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1174
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083205.
HG II FIXTURE SYSTEM
K090237 · Hiossen, Inc. · Apr 2009
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K083550 · Straumann USA · Feb 2009
STRAUMANN DENTAL IMPLANT SYSTEM
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MS SYSTEM
K083067 · Osstem Implant Co., Ltd. · Feb 2009
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · Zimmer Dental, Inc. · Dec 2008
BIOLOK MICRO-LOK IMPLANT SYSTEM
K081818 · BioHorizons Implant Systems, Inc. · Nov 2008