Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K-Number: K192535 · 2020-01-31
Decision Date2020-01-31
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is a medical device manufactured by Qinhuangdao Audental Metal Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-01-31 under approval number K192535. 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 Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia?
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is a medical device that received FDA 510(k) clearance on 2020-01-31. It is manufactured by Qinhuangdao Audental Metal Technology Co., Ltd.. The 510(k) number is K192535.
When was Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia approved by the FDA?
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia received FDA 510(k) clearance on 2020-01-31, under approval number K192535.
What company makes Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia?
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is manufactured by Qinhuangdao Audental Metal Technology Co., Ltd..
What is the FDA product code for Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia?
The FDA product code for Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia is EIH.
Related Clinical Trials
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.