TSIII BA Fixture

Implant, Endosseous, Root-form

OSSTEM IMPLANT Co., Ltd.

The following data is part of a premarket notification filed by Osstem Implant Co., Ltd. with the FDA for Tsiii Ba Fixture.

Pre-market Notification Details

• Device ID: K163088
• 510k Number: K163088
• Device Name: TSIII BA Fixture
• Classification: Implant, Endosseous, Root-form
• Applicant: OSSTEM IMPLANT Co., Ltd. 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, KR 612-070
• Contact: Hee Kwon
• 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: 2016-11-04
• Decision Date: 2017-04-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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