VALO Grand
FDA 510(k) K160551 · Ultradent Products, Inc.
510(k) numberK160551
Submission
- Device name
- VALO Grand
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- February 29, 2016
- Decision date
- July 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was VALO Grand cleared by the FDA?
VALO Grand (K160551) received a 510(k) decision of Substantially Equivalent on July 13, 2016, 135 days after the submission was received.
What is the product code of K160551?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.