ET III Bio-SA Fixture System

Implant, Endosseous, Root-form

HiOSSEN Inc.

The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Et Iii Bio-sa Fixture System.

Pre-market Notification Details

• Device ID: K151626
• 510k Number: K151626
• Device Name: ET III Bio-SA Fixture System
• Classification: Implant, Endosseous, Root-form
• Applicant: HiOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030
• Contact: David Kim
• Correspondent: David Kim; HiOSSEN Inc. 85 Ben Fairless Dr. 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: 2015-06-17
• Decision Date: 2016-07-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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