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FDA 510(k)

TENDER ORTHO BOND-ENA BOND-ENA ETCH

K-Number: K072978 · 2008-01-17

ApplicantMicerium S.P.A.
Decision Date2008-01-17
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TENDER ORTHO BOND-ENA BOND-ENA ETCH is the device name listed in this FDA 510(k) record. The listed applicant is Micerium S.P.A.. It received FDA 510(k) clearance on 2008-01-17 under 510(k) number K072978. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENDER ORTHO BOND-ENA BOND-ENA ETCH?

TENDER ORTHO BOND-ENA BOND-ENA ETCH is a medical device that received FDA 510(k) clearance on 2008-01-17. The listed applicant is Micerium S.P.A.. The 510(k) number is K072978.

When did TENDER ORTHO BOND-ENA BOND-ENA ETCH receive FDA 510(k) clearance?

TENDER ORTHO BOND-ENA BOND-ENA ETCH received FDA 510(k) clearance on 2008-01-17, under 510(k) number K072978.

Who is the listed applicant for TENDER ORTHO BOND-ENA BOND-ENA ETCH?

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

What is the FDA product code for TENDER ORTHO BOND-ENA BOND-ENA ETCH?

The FDA product code for TENDER ORTHO BOND-ENA BOND-ENA ETCH is DYH.

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Other records listing Micerium S.P.A. as applicant

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Official Source

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