Cleared Traditional

K233208 - NobelProcera Titanium ASC Abutment

K233208 is the FDA 510(k) clearance for NobelProcera Titanium ASC Abutment by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K233208 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
118d
Days
Class 2
Risk

K233208 is an FDA 510(k) clearance for the NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium. 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 January 24, 2024 after a review of 118 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 K233208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2023
Decision Date January 24, 2024
Days to Decision 118 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
9d faster than avg
Panel avg: 127d · This submission: 118d
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 K233208.
Zfx Abutments
K231915 · Zfx GmbH - A Company of Zimvie · Mar 2024
Oneday Implant Abutment
K231753 · Oneday Biotech Co., Ltd. · Feb 2024
TS Abutment System
K233194 · Osstem Implant Co., Ltd. · Feb 2024
MegaGen Dental Implant Abutment - Scan Healing Abutment
K233450 · Megagen Implant Co., Ltd. · Jan 2024
Ti Link Abutment
K232170 · Izenimplant Co., Ltd. · Jan 2024
DESS Dental Smart Solutions
K233316 · Terrats Medical SL · Jan 2024