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

FDA 510(k)

bright CT

K-Number: K231181 · 2023-12-14

Decision Date2023-12-14
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

bright CT is a medical device manufactured by Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2023-12-14 under approval number K231181. 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 bright CT?

bright CT is a medical device that received FDA 510(k) clearance on 2023-12-14. It is manufactured by Dentium Co., Ltd (Ict Branch). The 510(k) number is K231181.

When was bright CT approved by the FDA?

bright CT received FDA 510(k) clearance on 2023-12-14, under approval number K231181.

What company makes bright CT?

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

What is the FDA product code for bright CT?

The FDA product code for bright CT is OAS.

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

Related Devices (Code: OAS)

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.