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FDA 510(k)

TRILUX, Z-TONE, ACRY ROCK

K-Number: K022299 · 2002-10-07

ApplicantRuthibras Imp. Exp. Com. DE Materiais Odontologico
Decision Date2002-10-07
Product CodeELM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRILUX, Z-TONE, ACRY ROCK is the device name listed in this FDA 510(k) record. The listed applicant is Ruthibras Imp. Exp. Com. DE Materiais Odontologico. It received FDA 510(k) clearance on 2002-10-07 under 510(k) number K022299. 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 TRILUX, Z-TONE, ACRY ROCK?

TRILUX, Z-TONE, ACRY ROCK is a medical device that received FDA 510(k) clearance on 2002-10-07. The listed applicant is Ruthibras Imp. Exp. Com. DE Materiais Odontologico. The 510(k) number is K022299.

When did TRILUX, Z-TONE, ACRY ROCK receive FDA 510(k) clearance?

TRILUX, Z-TONE, ACRY ROCK received FDA 510(k) clearance on 2002-10-07, under 510(k) number K022299.

Who is the listed applicant for TRILUX, Z-TONE, ACRY ROCK?

The FDA 510(k) record lists Ruthibras Imp. Exp. Com. DE Materiais Odontologico as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRILUX, Z-TONE, ACRY ROCK?

The FDA product code for TRILUX, Z-TONE, ACRY ROCK 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.

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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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