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)

Paltop Conical Implant System

K-Number: K220200 · 2022-05-25

Decision Date2022-05-25
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Paltop Conical Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220200. 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 Conical Implant System?

Paltop Conical Implant System is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Paltop Advanced Dental Solutions, Ltd.. The 510(k) number is K220200.

When did Paltop Conical Implant System receive FDA 510(k) clearance?

Paltop Conical Implant System received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220200.

Who is the listed applicant for Paltop Conical Implant System?

The FDA 510(k) record lists Paltop Advanced Dental Solutions, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Paltop Conical Implant System?

The FDA product code for Paltop Conical Implant System is DZE.

Other records listing Paltop Advanced Dental Solutions, Ltd. as applicant

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.

Related Devices (Code: DZE)

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.

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.