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FDA 510(k)

rainbow CT

K-Number: K200271 · 2021-04-16

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

Device Summary

rainbow CT is a medical device manufactured by Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2021-04-16 under approval number K200271. 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 CT?

rainbow CT 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 K200271.

When was rainbow CT approved by the FDA?

rainbow CT received FDA 510(k) clearance on 2021-04-16, under approval number K200271.

What company makes rainbow CT?

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

What is the FDA product code for rainbow CT?

The FDA product code for rainbow CT is OAS.

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

K201247Intraoral Sensor K200270rainbow MCT 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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