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FDA 510(k)

TEMPORARY TOOTH REPLACEMENT

K-Number: K081900 · 2008-10-24

ApplicantOrmco Corp.
Decision Date2008-10-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPORARY TOOTH REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 2008-10-24 under 510(k) number K081900. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPORARY TOOTH REPLACEMENT?

TEMPORARY TOOTH REPLACEMENT is a medical device that received FDA 510(k) clearance on 2008-10-24. The listed applicant is Ormco Corp.. The 510(k) number is K081900.

When did TEMPORARY TOOTH REPLACEMENT receive FDA 510(k) clearance?

TEMPORARY TOOTH REPLACEMENT received FDA 510(k) clearance on 2008-10-24, under 510(k) number K081900.

Who is the listed applicant for TEMPORARY TOOTH REPLACEMENT?

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

What is the FDA product code for TEMPORARY TOOTH REPLACEMENT?

The FDA product code for TEMPORARY TOOTH REPLACEMENT is DZE.

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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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