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)

S.I.N. Dental Implant System

K-Number: K200992 · 2020-11-17

Decision Date2020-11-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

S.I.N. Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is S.I.N. - Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2020-11-17 under 510(k) number K200992. 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 S.I.N. Dental Implant System?

S.I.N. Dental Implant System is a medical device that received FDA 510(k) clearance on 2020-11-17. The listed applicant is S.I.N. - Sistema DE Implante Nacional S.A.. The 510(k) number is K200992.

When did S.I.N. Dental Implant System receive FDA 510(k) clearance?

S.I.N. Dental Implant System received FDA 510(k) clearance on 2020-11-17, under 510(k) number K200992.

Who is the listed applicant for S.I.N. Dental Implant System?

The FDA 510(k) record lists S.I.N. - Sistema DE Implante Nacional S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.I.N. Dental Implant System?

The FDA product code for S.I.N. Dental Implant System is DZE.

Other records listing S.I.N. - Sistema DE Implante Nacional S.A. 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.

View all 17 devices →

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.