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FDA 510(k)

OPAL SEAL

K-Number: K090355 · 2009-04-29

ApplicantUltradent Products, Inc.
Decision Date2009-04-29
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPAL 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 2009-04-29 under 510(k) number K090355. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPAL SEAL?

OPAL SEAL is a medical device that received FDA 510(k) clearance on 2009-04-29. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K090355.

When did OPAL SEAL receive FDA 510(k) clearance?

OPAL SEAL received FDA 510(k) clearance on 2009-04-29, under 510(k) number K090355.

Who is the listed applicant for OPAL 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 OPAL SEAL?

The FDA product code for OPAL SEAL is DYH.

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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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