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FDA 510(k)

GEBDI TRIBOS 501

K-Number: K092231 · 2009-11-24

ApplicantGebdi Dental-Products GmbH
Decision Date2009-11-24
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEBDI TRIBOS 501 is the device name listed in this FDA 510(k) record. The listed applicant is Gebdi Dental-Products GmbH. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K092231. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEBDI TRIBOS 501?

GEBDI TRIBOS 501 is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Gebdi Dental-Products GmbH. The 510(k) number is K092231.

When did GEBDI TRIBOS 501 receive FDA 510(k) clearance?

GEBDI TRIBOS 501 received FDA 510(k) clearance on 2009-11-24, under 510(k) number K092231.

Who is the listed applicant for GEBDI TRIBOS 501?

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

What is the FDA product code for GEBDI TRIBOS 501?

The FDA product code for GEBDI TRIBOS 501 is ELM.

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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