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FDA 510(k)

ORALUBE

K-Number: K090457 · 2009-05-21

ApplicantPulpdent Corporation
Decision Date2009-05-21
Product CodeONK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ORALUBE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2009-05-21 under 510(k) number K090457. The device is classified under product code ONK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORALUBE?

ORALUBE is a medical device that received FDA 510(k) clearance on 2009-05-21. The listed applicant is Pulpdent Corporation. The 510(k) number is K090457.

When did ORALUBE receive FDA 510(k) clearance?

ORALUBE received FDA 510(k) clearance on 2009-05-21, under 510(k) number K090457.

Who is the listed applicant for ORALUBE?

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

What is the FDA product code for ORALUBE?

The FDA product code for ORALUBE is ONK.

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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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