Cleared Traditional

K142260 - NobelActive

K142260 is an FDA 510(k) clearance for NobelActive, 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 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

FDA 510(k) Submission Details - K142260

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.

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 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 921
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K142260.
Straumann® Dental Implant System ¿ Roxolid® SLA Implants
K150938 · Straumann USA, LLC · Jul 2015
MiNi Internal Implant System
K150537 · Megagen Implant Co., Ltd. · Jul 2015
2014 InterActive/SwishActive System
K143011 · Implant Direct Sybron Manufacturing, LLC · Jul 2015
Hahn Tapered Implant System
K143353 · Prismatik Dentalcraft, Inc. · Apr 2015
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
K140091 · Megagen Implant Co., Ltd. · Dec 2014