FDA 510(k)

Perfit CL

K-Number: K223029 · 2023-06-20

Decision Date2023-06-20

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Perfit CL is the device name listed in this FDA 510(k) record. The listed applicant is Vatech Mcis Co., Ltd.. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K223029. 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 Perfit CL?

Perfit CL is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Vatech Mcis Co., Ltd.. The 510(k) number is K223029.

When did Perfit CL receive FDA 510(k) clearance?

Perfit CL received FDA 510(k) clearance on 2023-06-20, under 510(k) number K223029.

Who is the listed applicant for Perfit CL?

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

What is the FDA product code for Perfit CL?

The FDA product code for Perfit CL is EIH.

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 Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta 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.