Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

VALO Grand

K-Number: K160551 · 2016-07-13

Decision Date2016-07-13
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VALO Grand 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 2016-07-13 under 510(k) 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. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K160551.

When did VALO Grand receive FDA 510(k) clearance?

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

Who is the listed applicant for VALO Grand?

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 Grand?

The FDA product code for VALO Grand is EBZ.

Other records listing Ultradent Products, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 12 devices →

Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.