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 a medical device manufactured by Arum Dentistry Co., Ltd.. It received FDA 510(k) clearance on 2023-02-27 under approval 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. It is manufactured by Arum Dentistry Co., Ltd.. The 510(k) number is K223253.
When was Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) approved by the FDA?
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) received FDA 510(k) clearance on 2023-02-27, under approval number K223253.
What company makes Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)?
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) is manufactured by Arum Dentistry Co., Ltd..
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.
Related Clinical Trials
Other Devices by Arum Dentistry Co., Ltd.
Related Devices (Code: EIH)
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.