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FDA 510(k)

Intraoral Sensor

K-Number: K201247 · 2020-06-10

ApplicantDentium Co., Ltd (Ict Branch)
Decision Date2020-06-10
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Intraoral Sensor 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 2020-06-10 under 510(k) number K201247. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intraoral Sensor?

Intraoral Sensor is a medical device that received FDA 510(k) clearance on 2020-06-10. The listed applicant is Dentium Co., Ltd (Ict Branch). The 510(k) number is K201247.

When did Intraoral Sensor receive FDA 510(k) clearance?

Intraoral Sensor received FDA 510(k) clearance on 2020-06-10, under 510(k) number K201247.

Who is the listed applicant for Intraoral Sensor?

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 Intraoral Sensor?

The FDA product code for Intraoral Sensor is MQB.

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 CTK200270rainbow MCT

Related Devices (Code: MQB)

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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.

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