Cleared Traditional

K161655 - On1 Concept

K161655 is an FDA 510(k) clearance for On1 Concept, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K161655 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
257d
Days
Class 2
Risk

K161655 is an FDA 510(k) clearance for the On1 Concept. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on February 28, 2017 after a review of 257 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 - K161655

510(k) Number K161655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2016
Decision Date February 28, 2017
Days to Decision 257 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
130d slower than avg
Panel avg: 127d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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
CHARLEMAGNE CHUA

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 - NHA Abutment, Implant, Dental, Endosseous

All 541
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K161655.
ET US SS Prosthetic system
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K163350 · Dentsply Sirona · Mar 2017
Multi-unit Abutment Plus
K161416 · Nobel Biocare AB · Mar 2017
ET Hybrid Abutment
K162390 · Hiossen, Inc. · Jan 2017
Dentium CAD/CAM Abutments
K161713 · Dentium Co., Ltd. · Dec 2016
IPS e.max® Press Abutment Solutions for Viteo Base Ti
K160798 · Ivoclar Vivadent, AG · Dec 2016