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FDA 510(k)

OPAL BOND FLOW

K-Number: K100301 · 2010-04-29

ApplicantUltradent Products, Inc.
Decision Date2010-04-29
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPAL BOND FLOW 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 2010-04-29 under 510(k) number K100301. 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 BOND FLOW?

OPAL BOND FLOW is a medical device that received FDA 510(k) clearance on 2010-04-29. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K100301.

When did OPAL BOND FLOW receive FDA 510(k) clearance?

OPAL BOND FLOW received FDA 510(k) clearance on 2010-04-29, under 510(k) number K100301.

Who is the listed applicant for OPAL BOND FLOW?

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 BOND FLOW?

The FDA product code for OPAL BOND FLOW 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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