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FDA 510(k)

Straumann BLX Gold Abutments

K-Number: K200597 · 2020-08-19

ApplicantStraumann USA, LLC (On Behalf of Institut Straumann Ag)
Decision Date2020-08-19
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann BLX Gold Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K200597. 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 Straumann BLX Gold Abutments?

Straumann BLX Gold Abutments is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Straumann USA, LLC (On Behalf of Institut Straumann Ag). The 510(k) number is K200597.

When did Straumann BLX Gold Abutments receive FDA 510(k) clearance?

Straumann BLX Gold Abutments received FDA 510(k) clearance on 2020-08-19, under 510(k) number K200597.

Who is the listed applicant for Straumann BLX Gold Abutments?

The FDA 510(k) record lists Straumann USA, LLC (On Behalf of Institut Straumann Ag) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann BLX Gold Abutments?

The FDA product code for Straumann BLX Gold Abutments is NHA.

Other records listing Straumann USA, LLC (On Behalf of Institut Straumann Ag) 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.

K171757Straumann Screw Retained AbutmentsK171769Straumann PURE Ceramic Implants

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.

K253999Universal 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.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

Official Source

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

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