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FDA 510(k)

S.I.N. Instrument Kits

K-Number: K222514 · 2022-10-27

ApplicantS.I.N. – Sistema DE Implante Nacional S.A.
Decision Date2022-10-27
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

S.I.N. Instrument Kits is a medical device manufactured by S.I.N. – Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2022-10-27 under approval number K222514. 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 2022-10-27. It is manufactured by S.I.N. – Sistema DE Implante Nacional S.A.. The 510(k) number is K222514.

When was S.I.N. Instrument Kits approved by the FDA?

S.I.N. Instrument Kits received FDA 510(k) clearance on 2022-10-27, under approval number K222514.

What company makes S.I.N. Instrument Kits?

S.I.N. Instrument Kits is manufactured by S.I.N. – Sistema DE Implante Nacional S.A..

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 Devices by S.I.N. – Sistema DE Implante Nacional S.A.

K170392S.I.N. Implant System K170398S.I.N. Dental Implant System K221453S.I.N. Dental Implant System K230069S.I.N. Dental Implant System

Related Devices (Code: KCT)

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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.

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