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FDA 510(k)

ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM

K-Number: K101913 · 2011-03-11

ApplicantAnthogyr Sas
Decision Date2011-03-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM is the device name listed in this FDA 510(k) record. The listed applicant is Anthogyr Sas. It received FDA 510(k) clearance on 2011-03-11 under 510(k) number K101913. 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 ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM?

ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM is a medical device that received FDA 510(k) clearance on 2011-03-11. The listed applicant is Anthogyr Sas. The 510(k) number is K101913.

When did ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM receive FDA 510(k) clearance?

ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM received FDA 510(k) clearance on 2011-03-11, under 510(k) number K101913.

Who is the listed applicant for ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM?

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

What is the FDA product code for ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM?

The FDA product code for ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM is DZE.

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Other records listing Anthogyr Sas 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.

K161177Axiom PXK111532MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECEK102241ANTHOGYR IMPLANTEO IMPLANTOLOGY AND DENTAL SURGICAL MOTOR UNIT

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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