Cleared Traditional

K181869 - On1 Universal Abutment

K181869 is the FDA 510(k) clearance for On1 Universal Abutment by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K181869 · Nobel Biocare AB · Dental device
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Dec 2018
Decision
153d
Days
Class 2
Risk

K181869 is an FDA 510(k) clearance for the On1 Universal Abutment. 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 December 12, 2018 after a review of 153 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

Submission Details

510(k) Number K181869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2018
Decision Date December 12, 2018
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K181869.
MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
K182228 · Mis Implants Technologies , Ltd. · Jan 2019
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
K180564 · Medentika GmbH · Jan 2019
DIO CAD/CAM Abutment
K181037 · Dio Corporation · Dec 2018
A.B. Dental Devices Dental Implants System
K181381 · A.B. Dental Device , Ltd. · Nov 2018
Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System
K180184 · Dentalpoint AG · Nov 2018
Universal Base Abutment
K180899 · Nobel Biocare AB · Oct 2018