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FDA 510(k)

PURE Ceramic Implants

K-Number: K151328 · 2016-01-11

ApplicantStraumann USA
Decision Date2016-01-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PURE Ceramic Implants is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2016-01-11 under 510(k) number K151328. 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 PURE Ceramic Implants?

PURE Ceramic Implants is a medical device that received FDA 510(k) clearance on 2016-01-11. The listed applicant is Straumann USA. The 510(k) number is K151328.

When did PURE Ceramic Implants receive FDA 510(k) clearance?

PURE Ceramic Implants received FDA 510(k) clearance on 2016-01-11, under 510(k) number K151328.

Who is the listed applicant for PURE Ceramic Implants?

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

What is the FDA product code for PURE Ceramic Implants?

The FDA product code for PURE Ceramic 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 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 SystemsK171784Straumann Dental Implant System

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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