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)

Erran Dental Zirconia

K-Number: K182068 · 2018-12-13

ApplicantHangzhou Erran Technology Co., Ltd.
Decision Date2018-12-13
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Erran Dental Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Erran Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182068. 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 Erran Dental Zirconia?

Erran Dental Zirconia is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Hangzhou Erran Technology Co., Ltd.. The 510(k) number is K182068.

When did Erran Dental Zirconia receive FDA 510(k) clearance?

Erran Dental Zirconia received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182068.

Who is the listed applicant for Erran Dental Zirconia?

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

What is the FDA product code for Erran Dental Zirconia?

The FDA product code for Erran Dental Zirconia 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 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.

↑