Cleared Traditional

K142260 - NobelActive

K142260 is the FDA 510(k) clearance for NobelActive by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K142260 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2015
Decision
270d
Days
Class 2
Risk

K142260 is an FDA 510(k) clearance for the NobelActive. 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 May 11, 2015 after a review of 270 days - an extended review cycle.

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 K142260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2014
Decision Date May 11, 2015
Days to Decision 270 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
143d slower than avg
Panel avg: 127d · This submission: 270d
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 Consultant

Nobel Biocare USA, LLC
Ji Eun Hwang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 422
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K142260.
TREFOIL System
K152836 · Nobel Biocare AB · Apr 2016
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K153758 · Institut Straumann AG · Mar 2016
NobelZygoma 45°
K152093 · Nobel Biocare AB · Mar 2016
NOBELACTIVE WIDE PLATFORM (WP)
K133731 · Nobel Biocare AB · May 2014
TS IMPLANT SYSTEM
K121585 · Osstem Implant Co., Ltd. · Jan 2013
TS FIXTURE SYSTEM
K121995 · Osstem Implant Co., Ltd. · Nov 2012