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FDA 510(k)

OSTEOGRAF/N-300

K-Number: K071817 · 2007-09-04

ApplicantDentsply Interntional
Decision Date2007-09-04
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSTEOGRAF/N-300 is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2007-09-04 under 510(k) number K071817. 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 OSTEOGRAF/N-300?

OSTEOGRAF/N-300 is a medical device that received FDA 510(k) clearance on 2007-09-04. The listed applicant is Dentsply Interntional. The 510(k) number is K071817.

When did OSTEOGRAF/N-300 receive FDA 510(k) clearance?

OSTEOGRAF/N-300 received FDA 510(k) clearance on 2007-09-04, under 510(k) number K071817.

Who is the listed applicant for OSTEOGRAF/N-300?

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

What is the FDA product code for OSTEOGRAF/N-300?

The FDA product code for OSTEOGRAF/N-300 is LYC.

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Other records listing Dentsply Interntional as applicant

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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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