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FDA 510(k)

VALO X, VALO X Accessory Lenses

K-Number: K220471 · 2022-02-22

Decision Date2022-02-22
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VALO X, VALO X Accessory Lenses 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 2022-02-22 under 510(k) number K220471. 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 X, VALO X Accessory Lenses?

VALO X, VALO X Accessory Lenses is a medical device that received FDA 510(k) clearance on 2022-02-22. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K220471.

When did VALO X, VALO X Accessory Lenses receive FDA 510(k) clearance?

VALO X, VALO X Accessory Lenses received FDA 510(k) clearance on 2022-02-22, under 510(k) number K220471.

Who is the listed applicant for VALO X, VALO X Accessory Lenses?

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 X, VALO X Accessory Lenses?

The FDA product code for VALO X, VALO X Accessory Lenses 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.