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)

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)

K-Number: K223253 · 2023-02-27

ApplicantArum Dentistry Co., Ltd.
Decision Date2023-02-27
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) 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 2023-02-27 under 510(k) number K223253. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)?

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) is a medical device that received FDA 510(k) clearance on 2023-02-27. The listed applicant is Arum Dentistry Co., Ltd.. The 510(k) number is K223253.

When did Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) receive FDA 510(k) clearance?

Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) received FDA 510(k) clearance on 2023-02-27, under 510(k) number K223253.

Who is the listed applicant for Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)?

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 Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)?

The FDA product code for Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) is EIH.

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: EIH)

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.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.

↑