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FDA 510(k)

ENDO-SEAL

K-Number: K971899 · 1997-06-26

ApplicantUltradent Products, Inc.
Decision Date1997-06-26
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDO-SEAL 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 1997-06-26 under 510(k) number K971899. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-SEAL?

ENDO-SEAL is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K971899.

When did ENDO-SEAL receive FDA 510(k) clearance?

ENDO-SEAL received FDA 510(k) clearance on 1997-06-26, under 510(k) number K971899.

Who is the listed applicant for ENDO-SEAL?

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 ENDO-SEAL?

The FDA product code for ENDO-SEAL is KIF.

Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: KIF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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