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)

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 the device name listed in this FDA 510(k) record. The listed applicant is Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) 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. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K210817.

When did C&B 5.0 Hybrid receive FDA 510(k) clearance?

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

Who is the listed applicant for C&B 5.0 Hybrid?

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

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

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

Other records listing Arum Dentistry Co., Ltd. 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.

K250280SD TL Implant SystemK250063ARENA Star, Galaxy StarK241703SD Implant SystemK242753SD TL Implant SystemK242245Customized AbutmentK232559C&B NFH Hybrid

View all 17 devices →

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials 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.

↑