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FDA 510(k)

OPAL BAND CEMENT

K-Number: K111696 · 2011-09-07

ApplicantUltradent Products, Inc.
Decision Date2011-09-07
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPAL BAND CEMENT 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 2011-09-07 under 510(k) number K111696. 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 BAND CEMENT?

OPAL BAND CEMENT is a medical device that received FDA 510(k) clearance on 2011-09-07. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K111696.

When did OPAL BAND CEMENT receive FDA 510(k) clearance?

OPAL BAND CEMENT received FDA 510(k) clearance on 2011-09-07, under 510(k) number K111696.

Who is the listed applicant for OPAL BAND CEMENT?

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 BAND CEMENT?

The FDA product code for OPAL BAND CEMENT 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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