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FDA 510(k)

Straumann Dental Implant System

K-Number: K171784 · 2018-01-19

ApplicantStraumann USA, LLC
Decision Date2018-01-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Straumann Dental Implant System 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 2018-01-19 under 510(k) number K171784. 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 Dental Implant System?

Straumann Dental Implant System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Straumann USA, LLC. The 510(k) number is K171784.

When did Straumann Dental Implant System receive FDA 510(k) clearance?

Straumann Dental Implant System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171784.

Who is the listed applicant for Straumann Dental Implant System?

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 Dental Implant System?

The FDA product code for Straumann Dental Implant System 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.

NCT06086873Investigating Implant Surface Effect on Osseointegration: NGA vs. ModSLARECRUITINGNCT07518615Clinical Safety and Effectiveness of the Straumann Dynamic Navigation System FalconRECRUITINGNCT07744776Effect of Implant Macro-Design and Surface Treatment on Insertion Torque and Early Implant Stability Quotient (ISQ)RECRUITING

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 ImplantsK192401Straumann Screw-Retained AbutmentsK190662MRI Compatibility for Existing Straumann Dental Implant SystemsK162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment

View all 9 devices →

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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