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FDA 510(k)

VALO, MODEL 5919

K-Number: K083647 · 2009-01-23

ApplicantUltradent Products, Inc.
Decision Date2009-01-23
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VALO, MODEL 5919 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 2009-01-23 under 510(k) number K083647. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALO, MODEL 5919?

VALO, MODEL 5919 is a medical device that received FDA 510(k) clearance on 2009-01-23. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K083647.

When did VALO, MODEL 5919 receive FDA 510(k) clearance?

VALO, MODEL 5919 received FDA 510(k) clearance on 2009-01-23, under 510(k) number K083647.

Who is the listed applicant for VALO, MODEL 5919?

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 VALO, MODEL 5919?

The FDA product code for VALO, MODEL 5919 is EBZ.

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Related Devices (Code: EBZ)

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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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