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FDA 510(k)

rainbow MCT

K-Number: K200270 · 2021-04-16

ApplicantDentium Co., Ltd (Ict Branch)
Decision Date2021-04-16
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

rainbow MCT is a medical device manufactured by Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2021-04-16 under approval number K200270. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the rainbow MCT?

rainbow MCT is a medical device that received FDA 510(k) clearance on 2021-04-16. It is manufactured by Dentium Co., Ltd (Ict Branch). The 510(k) number is K200270.

When was rainbow MCT approved by the FDA?

rainbow MCT received FDA 510(k) clearance on 2021-04-16, under approval number K200270.

What company makes rainbow MCT?

rainbow MCT is manufactured by Dentium Co., Ltd (Ict Branch).

What is the FDA product code for rainbow MCT?

The FDA product code for rainbow MCT is OAS.

Other Devices by Dentium Co., Ltd (Ict Branch)

K201247Intraoral Sensor K200271rainbow CT K231181bright CT

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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.

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