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FDA 510(k)

ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V

K-Number: K022300 · 2002-10-03

ApplicantDental Vipi Ltda
Decision Date2002-10-03
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V is the device name listed in this FDA 510(k) record. The listed applicant is Dental Vipi Ltda. It received FDA 510(k) clearance on 2002-10-03 under 510(k) number K022300. 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 ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V?

ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V is a medical device that received FDA 510(k) clearance on 2002-10-03. The listed applicant is Dental Vipi Ltda. The 510(k) number is K022300.

When did ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V receive FDA 510(k) clearance?

ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V received FDA 510(k) clearance on 2002-10-03, under 510(k) number K022300.

Who is the listed applicant for ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V?

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

What is the FDA product code for ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V?

The FDA product code for ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V 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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