Esthetic Colorant
K-Number: K220369 · 2022-09-23
ApplicantKuraray Noritake Dental, Inc.
Decision Date2022-09-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Esthetic Colorant is a medical device manufactured by Kuraray Noritake Dental, Inc.. It received FDA 510(k) clearance on 2022-09-23 under approval number K220369. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Esthetic Colorant?
Esthetic Colorant is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Kuraray Noritake Dental, Inc.. The 510(k) number is K220369.
When was Esthetic Colorant approved by the FDA?
Esthetic Colorant received FDA 510(k) clearance on 2022-09-23, under approval number K220369.
What company makes Esthetic Colorant?
Esthetic Colorant is manufactured by Kuraray Noritake Dental, Inc..
What is the FDA product code for Esthetic Colorant?
The FDA product code for Esthetic Colorant is EIH.
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Related Devices (Code: EIH)
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.