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)

Kontact Dental Implant System

K-Number: K210220 · 2021-06-18

ApplicantBiotech Dental, Sas
Decision Date2021-06-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Kontact Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Biotech Dental, Sas. It received FDA 510(k) clearance on 2021-06-18 under 510(k) number K210220. 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 Kontact Dental Implant System?

Kontact Dental Implant System is a medical device that received FDA 510(k) clearance on 2021-06-18. The listed applicant is Biotech Dental, Sas. The 510(k) number is K210220.

When did Kontact Dental Implant System receive FDA 510(k) clearance?

Kontact Dental Implant System received FDA 510(k) clearance on 2021-06-18, under 510(k) number K210220.

Who is the listed applicant for Kontact Dental Implant System?

The FDA 510(k) record lists Biotech Dental, Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kontact Dental Implant System?

The FDA product code for Kontact Dental Implant System is DZE.

Other records listing Biotech Dental, Sas 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.

K213997Kontact Dental Implant SystemK212068Biotech Dental Kits

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , 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.

↑