Cleared Traditional

K223677 - Titanium Abutment Blank Nobel Biocare N...

K223677 is the FDA 510(k) clearance for Titanium Abutment Blank Nobel Biocare N... by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K223677 · Nobel Biocare AB · Dental device
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Apr 2023
Decision
141d
Days
Class 2
Risk

K223677 is an FDA 510(k) clearance for the Titanium Abutment Blank Nobel Biocare N1 TCC. 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 April 28, 2023 after a review of 141 days - within the typical 510(k) review window.

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 K223677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2022
Decision Date April 28, 2023
Days to Decision 141 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
14d slower than avg
Panel avg: 127d · This submission: 141d
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 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 K223677.
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K222636 · Hiossen, Inc. · Apr 2023
Customized Abutment
K223634 · Arum Dentistry Co., Ltd. · Apr 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218 · Dental Direkt GmbH · Apr 2023
Klockner Abutments
K230103 · SOADCO, S.L. · Apr 2023
TIB Abutments
K222469 · Southern Implants (Pty), Ltd. · Apr 2023