Cleared Abbreviated

K132814 - SFI-BAR IMPLANT ABUTMENTS

K132814 is an FDA 510(k) clearance for SFI-BAR IMPLANT ABUTMENTS, manufactured by Sterngold Dental, LLC. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 169-day FDA review.

K132814 · Sterngold Dental, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
169d
Days
Class 2
Risk

K132814 is an FDA 510(k) clearance for the SFI-BAR IMPLANT ABUTMENTS. 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 Sterngold Dental, LLC (Attleboro, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 169 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K132814

510(k) Number K132814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2013
Decision Date February 25, 2014
Days to Decision 169 days
Submission Type Abbreviated
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
41d slower than avg
Panel avg: 128d · This submission: 169d
Pathway characteristics
Standards-based clearance path.

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 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K132814.
ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], ORA 4.0MM [S]
K133791 · Sterngold Dental, LLC · Apr 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT REPLACE
K133377 · Nobel Biocare AB · Apr 2014
SFI-ANCHOR
K130618 · Cendres & Metaux SA · Mar 2014
NEODENT IMPLANT SYSTEM
K133696 · Jjgc Industria E Comercio DE Materiais Dentarios S · Feb 2014
STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
K132219 · Straumann USA, LLC · Feb 2014
NOBELPROCERA ANGULATED SCREW CHANNEL ABUTMENT CONICAL CONNECTION
K132746 · Nobel Biocare USA, LLC · Jan 2014