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)

Implanova

K-Number: K210523 · 2021-09-30

ApplicantDental Evolutions, Inc.
Decision Date2021-09-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Implanova is a medical device manufactured by Dental Evolutions, Inc.. It received FDA 510(k) clearance on 2021-09-30 under approval number K210523. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Implanova?

Implanova is a medical device that received FDA 510(k) clearance on 2021-09-30. It is manufactured by Dental Evolutions, Inc.. The 510(k) number is K210523.

When was Implanova approved by the FDA?

Implanova received FDA 510(k) clearance on 2021-09-30, under approval number K210523.

What company makes Implanova?

Implanova is manufactured by Dental Evolutions, Inc..

What is the FDA product code for Implanova?

The FDA product code for Implanova is DZE.

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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.

↑