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FDA 510(k)

C&B 5.0 Hybrid

K-Number: K210817 · 2021-12-08

ApplicantArum Dentistry Co., Ltd.
Decision Date2021-12-08
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C&B 5.0 Hybrid is a medical device manufactured by Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under approval number K210817. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C&B 5.0 Hybrid?

C&B 5.0 Hybrid is a medical device that received FDA 510(k) clearance on 2021-12-08. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K210817.

When was C&B 5.0 Hybrid approved by the FDA?

C&B 5.0 Hybrid received FDA 510(k) clearance on 2021-12-08, under approval number K210817.

What company makes C&B 5.0 Hybrid?

C&B 5.0 Hybrid is manufactured by Arum Dentistry Co., Ltd..

What is the FDA product code for C&B 5.0 Hybrid?

The FDA product code for C&B 5.0 Hybrid is EBG.

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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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