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)

Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)

K-Number: K240912 · 2024-05-31

ApplicantAnhui Miisen Intelligence Technology Co., Ltd.
Decision Date2024-05-31
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) is a medical device manufactured by Anhui Miisen Intelligence Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-31 under approval number K240912. 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 Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)?

Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) is a medical device that received FDA 510(k) clearance on 2024-05-31. It is manufactured by Anhui Miisen Intelligence Technology Co., Ltd.. The 510(k) number is K240912.

When was Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) approved by the FDA?

Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) received FDA 510(k) clearance on 2024-05-31, under approval number K240912.

What company makes Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)?

Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) is manufactured by Anhui Miisen Intelligence Technology Co., Ltd..

What is the FDA product code for Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)?

The FDA product code for Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) is EIH.

Related Clinical Trials

NCT07608406 Modified Versus Clear Twin Block for Skeletal Class II Malocclusion NOT_YET_RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED NCT07571278 Pain Perception During Inferior Alveolar Nerve Block Administration in Children Using Vibraject and Dental Vibe Versus Conventional Syringe NOT_YET_RECRUITING NCT04695899 Zirconia Implants for Replacement of a Single Tooth ACTIVE_NOT_RECRUITING NCT07534072 Efficacy of Skeletally Anchored Modified Leaf Expander in Maxillary Molar Distalization COMPLETED

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

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.

↑