Cleared Traditional

K132746 - NOBELPROCERA ANGULATED SCREW CHANNEL AB...

K132746 is an FDA 510(k) clearance for NOBELPROCERA ANGULATED SCREW CHANNEL AB..., manufactured by Nobel Biocare USA, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K132746 · Nobel Biocare USA, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
149d
Days
Class 2
Risk

K132746 is an FDA 510(k) clearance for the NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION. 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 USA, LLC (Yorba Linda,, US). The FDA issued a Cleared decision on January 30, 2014 after a review of 149 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 USA, LLC devices

FDA 510(k) Submission Details - K132746

510(k) Number K132746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2013
Decision Date January 30, 2014
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 127d · This submission: 149d
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 Peers - NHA Abutment, Implant, Dental, Endosseous

All 559
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K132746.
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ANKYLOS SYNCONE ABUTMENT 5(DEGREE)
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K132844 · Straumann USA, LLC · Jan 2014
ET PROSTHETIC SYSTEM
K130662 · Osstem Implant Co., Ltd. · Jan 2014