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

FDA 510(k)

VALO Grand Corded

K-Number: K190627 · 2019-04-29

Decision Date2019-04-29
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VALO Grand Corded is a medical device manufactured by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2019-04-29 under approval number K190627. 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 Corded?

VALO Grand Corded is a medical device that received FDA 510(k) clearance on 2019-04-29. It is manufactured by Ultradent Products, Inc.. The 510(k) number is K190627.

When was VALO Grand Corded approved by the FDA?

VALO Grand Corded received FDA 510(k) clearance on 2019-04-29, under approval number K190627.

What company makes VALO Grand Corded?

VALO Grand Corded is manufactured by Ultradent Products, Inc..

What is the FDA product code for VALO Grand Corded?

The FDA product code for VALO Grand Corded is EBZ.

Other Devices by Ultradent Products, Inc.

View all 11 devices →

Related Devices (Code: EBZ)

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.