EM SA Implant System

Implant, Endosseous, Root-form

Hiossen, Inc.

The following data is part of a premarket notification filed by Hiossen, Inc. with the FDA for Em Sa Implant System.

Pre-market Notification Details

• Device ID: K191201
• 510k Number: K191201
• Device Name: EM SA Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030
• Contact: Peter Lee
• Correspondent: Peter Lee; Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-05-06
• Decision Date: 2019-11-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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