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FDA 510(k)

VALO Grand

K-Number: K160551 · 2016-07-13

ApplicantUltradent Products, Inc.
Decision Date2016-07-13
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VALO Grand is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2016-07-13 under approval number K160551. 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 Grand?

VALO Grand is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K160551.

When was VALO Grand approved by the FDA?

VALO Grand received FDA 510(k) clearance on 2016-07-13, under approval number K160551.

What company makes VALO Grand?

VALO Grand is manufactured by Ultradent Products, Inc..

What is the FDA product code for VALO Grand?

The FDA product code for VALO Grand is EBZ.

Other Devices by Ultradent Products, Inc.

K173163ChlorCid, ChlorCid V, ChlorCid Surf K190627VALO Grand Corded K211905UltraCal XS K211237UltraTemp Rez II K210550VALO Grand Corded and Accessory Lenses K221909J-Temp

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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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