Cleared Traditional

K102436 - NOBEL ACTIVE 3.0

K102436 is the FDA 510(k) clearance for NOBEL ACTIVE 3.0 by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K102436 · Nobel Biocare AB · Dental device
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Dec 2010
Decision
105d
Days
Class 2
Risk

K102436 is an FDA 510(k) clearance for the NOBEL ACTIVE 3.0. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on December 9, 2010 after a review of 105 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

Submission Details

510(k) Number K102436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2010
Decision Date December 09, 2010
Days to Decision 105 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
22d faster than avg
Panel avg: 127d · This submission: 105d
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 506
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K102436.
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K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010
GS III SYSTEM
K091208 · Osstem Implant Co., Ltd. · Mar 2010
HG II SHORT FIXTURE SYSTEM
K091678 · Osstem Implant Co., Ltd. · Feb 2010