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FDA 510(k)

Straumann Screw-Retained Abutments

K-Number: K192401 · 2020-04-06

ApplicantStraumann USA, LLC
Decision Date2020-04-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Screw-Retained Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA, LLC. It received FDA 510(k) clearance on 2020-04-06 under 510(k) number K192401. 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 Screw-Retained Abutments?

Straumann Screw-Retained Abutments is a medical device that received FDA 510(k) clearance on 2020-04-06. The listed applicant is Straumann USA, LLC. The 510(k) number is K192401.

When did Straumann Screw-Retained Abutments receive FDA 510(k) clearance?

Straumann Screw-Retained Abutments received FDA 510(k) clearance on 2020-04-06, under 510(k) number K192401.

Who is the listed applicant for Straumann Screw-Retained Abutments?

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

What is the FDA product code for Straumann Screw-Retained Abutments?

The FDA product code for Straumann Screw-Retained Abutments is NHA.

Related Clinical Trials

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NCT07701200OT-Bridge System Versus Multiunit Abutment for Mandibular All On-4 Screw Retained Prostheses.COMPLETED

Other records listing Straumann USA, 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.

K241575Straumann® Anatomic Healing Abutments XC (AHA)K203753Straumann Surgical CassettesK202942Straumann 4 mm Short ImplantsK190662MRI Compatibility for Existing Straumann Dental Implant SystemsK171784Straumann Dental Implant SystemK162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

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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

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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