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FDA 510(k)

OSSATURA DENTAL

K-Number: K042706 · 2004-10-20

ApplicantIsotis Orthobiologics, Inc.
Decision Date2004-10-20
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSATURA DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Isotis Orthobiologics, Inc.. It received FDA 510(k) clearance on 2004-10-20 under 510(k) number K042706. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSATURA DENTAL?

OSSATURA DENTAL is a medical device that received FDA 510(k) clearance on 2004-10-20. The listed applicant is Isotis Orthobiologics, Inc.. The 510(k) number is K042706.

When did OSSATURA DENTAL receive FDA 510(k) clearance?

OSSATURA DENTAL received FDA 510(k) clearance on 2004-10-20, under 510(k) number K042706.

Who is the listed applicant for OSSATURA DENTAL?

The FDA 510(k) record lists Isotis Orthobiologics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSATURA DENTAL?

The FDA product code for OSSATURA DENTAL is LYC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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