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. Instrument Kits

K-Number: K212404 · 2021-11-03

ApplicantS.I.N. - Sistema DE Implante Nacional S.A.
Decision Date2021-11-03
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

S.I.N. Instrument Kits 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 2021-11-03 under 510(k) number K212404. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S.I.N. Instrument Kits?

S.I.N. Instrument Kits is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is S.I.N. - Sistema DE Implante Nacional S.A.. The 510(k) number is K212404.

When did S.I.N. Instrument Kits receive FDA 510(k) clearance?

S.I.N. Instrument Kits received FDA 510(k) clearance on 2021-11-03, under 510(k) number K212404.

Who is the listed applicant for S.I.N. Instrument Kits?

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. Instrument Kits?

The FDA product code for S.I.N. Instrument Kits is KCT.

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.

K240609S.I.N. Dental Implant SystemK241378S.I.N. Instrument KitsK232821S.I.N. Dental Implant SystemK231127S.I.N. Dental Implant SystemK230069S.I.N. Dental Implant SystemK221453S.I.N. Dental Implant System

View all 17 devices →

Related Devices (Code: KCT)

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.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

↑