S.I.N. Dental Implant System

Implant, Endosseous, Root-form

S.I.N. - Sistema De Implante Nacional S.A.

The following data is part of a premarket notification filed by S.i.n. - Sistema De Implante Nacional S.a. with the FDA for S.i.n. Dental Implant System.

Pre-market Notification Details

• Device ID: K222231
• 510k Number: K222231
• Device Name: S.I.N. Dental Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: S.I.N. - Sistema De Implante Nacional S.A. Avenida Vereador Abel Ferreira, 1100 Sao Paulo, BR 03340-000
• Contact: Denise Domiciano
• Correspondent: Kevin A. Thomas; PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, CA 92130
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-07-25
• Decision Date: 2022-10-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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