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FDA 510(k)

SFI BAR ABUTMENTS

K-Number: K130183 · 2013-07-07

ApplicantSterngold Dental, LLC
Decision Date2013-07-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SFI BAR ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Sterngold Dental, LLC. It received FDA 510(k) clearance on 2013-07-07 under 510(k) number K130183. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SFI BAR ABUTMENTS?

SFI BAR ABUTMENTS is a medical device that received FDA 510(k) clearance on 2013-07-07. The listed applicant is Sterngold Dental, LLC. The 510(k) number is K130183.

When did SFI BAR ABUTMENTS receive FDA 510(k) clearance?

SFI BAR ABUTMENTS received FDA 510(k) clearance on 2013-07-07, under 510(k) number K130183.

Who is the listed applicant for SFI BAR ABUTMENTS?

The FDA 510(k) record lists Sterngold Dental, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SFI BAR ABUTMENTS?

The FDA product code for SFI BAR ABUTMENTS is NHA.

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Other records listing Sterngold Dental, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmK153173MOR Implant SystemK130408ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENTK111798STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ...

Related Devices (Code: NHA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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