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FDA 510(k)

ABSOLUTE AMERICA

K-Number: K050571 · 2005-11-02

ApplicantEurodent S.P.A.
Decision Date2005-11-02
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ABSOLUTE AMERICA is the device name listed in this FDA 510(k) record. The listed applicant is Eurodent S.P.A.. It received FDA 510(k) clearance on 2005-11-02 under 510(k) number K050571. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABSOLUTE AMERICA?

ABSOLUTE AMERICA is a medical device that received FDA 510(k) clearance on 2005-11-02. The listed applicant is Eurodent S.P.A.. The 510(k) number is K050571.

When did ABSOLUTE AMERICA receive FDA 510(k) clearance?

ABSOLUTE AMERICA received FDA 510(k) clearance on 2005-11-02, under 510(k) number K050571.

Who is the listed applicant for ABSOLUTE AMERICA?

The FDA 510(k) record lists Eurodent S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSOLUTE AMERICA?

The FDA product code for ABSOLUTE AMERICA is EIA.

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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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