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)

Paltop Narrow Implant

K-Number: K210117 · 2021-11-30

ApplicantPaltop Advanced Dental Solutions, Ltd.
Decision Date2021-11-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Paltop Narrow Implant is a medical device manufactured by Paltop Advanced Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2021-11-30 under approval number K210117. 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 Paltop Narrow Implant?

Paltop Narrow Implant is a medical device that received FDA 510(k) clearance on 2021-11-30. It is manufactured by Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K210117.

When was Paltop Narrow Implant approved by the FDA?

Paltop Narrow Implant received FDA 510(k) clearance on 2021-11-30, under approval number K210117.

What company makes Paltop Narrow Implant?

Paltop Narrow Implant is manufactured by Paltop Advanced Dental Solutions, Ltd..

What is the FDA product code for Paltop Narrow Implant?

The FDA product code for Paltop Narrow Implant is DZE.

Related Clinical Trials

NCT05236439 Study of a Cilioscleral Interposition Device (CID) SV22 in Patients With Primary Open Angle Glaucoma and Narrow Angle Glaucoma COMPLETED NCT05625958 Clinical Study Evaluating the Efficacy and Safety of CID v2.2 in Glaucoma Surgery ACTIVE_NOT_RECRUITING

Other Devices by Paltop Advanced Dental Solutions, Ltd.

K220200Paltop Conical Implant System K232740Paltop Short Implants K243983Paltop Dental Implant System

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.

↑