FDA 510(k)

INNI-CERA

K-Number: K211308 · 2021-10-04

Decision Date2021-10-04

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

INNI-CERA is the device name listed in this FDA 510(k) record. The listed applicant is Aon Co., Ltd.. It received FDA 510(k) clearance on 2021-10-04 under 510(k) number K211308. 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 INNI-CERA?

INNI-CERA is a medical device that received FDA 510(k) clearance on 2021-10-04. The listed applicant is Aon Co., Ltd.. The 510(k) number is K211308.

When did INNI-CERA receive FDA 510(k) clearance?

INNI-CERA received FDA 510(k) clearance on 2021-10-04, under 510(k) number K211308.

Who is the listed applicant for INNI-CERA?

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

What is the FDA product code for INNI-CERA?

The FDA product code for INNI-CERA 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.