VALO X, VALO X Accessory Lenses
FDA 510(k) K220471 · Ultradent Products, Inc.
510(k) numberK220471
Submission
- Device name
- VALO X, VALO X Accessory Lenses
- Applicant
- Ultradent Products, Inc.
South Jordan, UT, US - Received
- February 18, 2022
- Decision date
- February 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was VALO X, VALO X Accessory Lenses cleared by the FDA?
VALO X, VALO X Accessory Lenses (K220471) received a 510(k) decision of Substantially Equivalent on February 22, 2022, 4 days after the submission was received.
What is the product code of K220471?
The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.