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FDA 510(k)

PERMALUTE, TRY-IN PASTE

K-Number: K971898 · 1997-06-24

ApplicantUltradent Products, Inc.
Decision Date1997-06-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMALUTE, TRY-IN PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971898. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMALUTE, TRY-IN PASTE?

PERMALUTE, TRY-IN PASTE is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K971898.

When did PERMALUTE, TRY-IN PASTE receive FDA 510(k) clearance?

PERMALUTE, TRY-IN PASTE received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971898.

Who is the listed applicant for PERMALUTE, TRY-IN PASTE?

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

What is the FDA product code for PERMALUTE, TRY-IN PASTE?

The FDA product code for PERMALUTE, TRY-IN PASTE is EBF.

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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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