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FDA 510(k)

Straumann 4 mm Short Implants

K-Number: K202942 · 2021-02-08

ApplicantStraumann USA, LLC
Decision Date2021-02-08
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann 4 mm Short Implants 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 2021-02-08 under 510(k) number K202942. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Straumann 4 mm Short Implants?

Straumann 4 mm Short Implants is a medical device that received FDA 510(k) clearance on 2021-02-08. The listed applicant is Straumann USA, LLC. The 510(k) number is K202942.

When did Straumann 4 mm Short Implants receive FDA 510(k) clearance?

Straumann 4 mm Short Implants received FDA 510(k) clearance on 2021-02-08, under 510(k) number K202942.

Who is the listed applicant for Straumann 4 mm Short Implants?

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 4 mm Short Implants?

The FDA product code for Straumann 4 mm Short Implants is DZE.

Related Clinical Trials

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.

NCT03908177Comparison of Clinical Performance and Safety of Zirconia vs. Titanium Implants: a Multi-national RCT.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 CassettesK192401Straumann Screw-Retained AbutmentsK190662MRI 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: DZE)

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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