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FDA 510(k)

MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE

K-Number: K032750 · 2003-10-02

ApplicantFriandent GmbH
Decision Date2003-10-02
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE is the device name listed in this FDA 510(k) record. The listed applicant is Friandent GmbH. It received FDA 510(k) clearance on 2003-10-02 under 510(k) number K032750. 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 MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE?

MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE is a medical device that received FDA 510(k) clearance on 2003-10-02. The listed applicant is Friandent GmbH. The 510(k) number is K032750.

When did MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE receive FDA 510(k) clearance?

MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE received FDA 510(k) clearance on 2003-10-02, under 510(k) number K032750.

Who is the listed applicant for MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE?

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

What is the FDA product code for MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE?

The FDA product code for MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE 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.

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Other records listing Friandent GmbH 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.

K030639XIVE 3.0 DENTAL IMPLANT SYSTEM

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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