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FDA 510(k)

FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505

K-Number: K080249 · 2008-02-08

ApplicantUltradent Products, Inc.
Decision Date2008-02-08
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 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 2008-02-08 under 510(k) number K080249. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505?

FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 is a medical device that received FDA 510(k) clearance on 2008-02-08. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K080249.

When did FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 receive FDA 510(k) clearance?

FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 received FDA 510(k) clearance on 2008-02-08, under 510(k) number K080249.

Who is the listed applicant for FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505?

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 FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505?

The FDA product code for FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 is LBH.

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Related Devices (Code: LBH)

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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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