Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2021-04-16 under 510(k) 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. The listed applicant is Dentium Co., Ltd (Ict Branch). The 510(k) number is K200270.

When did rainbow MCT receive FDA 510(k) clearance?

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

Who is the listed applicant for rainbow MCT?

The FDA 510(k) record lists Dentium Co., Ltd (Ict Branch) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for rainbow MCT?

The FDA product code for rainbow MCT is OAS.

Other records listing Dentium Co., Ltd (Ict Branch) 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.

K231181bright CTK200271rainbow CTK201247Intraoral Sensor

Related Devices (Code: OAS)

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.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

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.

↑