US/GS ULTRA WIDE SYSTEM

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 Us/gs Ultra Wide System.

Pre-market Notification Details

• Device ID: K073465
• 510k Number: K073465
• Device Name: US/GS ULTRA WIDE SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: OSSTEM IMPLANT CO.,LTD ONE BEN FAIRLESS DR. Fairless Hills, PA 19030
• Contact: Min Joo Kim
• Correspondent: Min Joo Kim; OSSTEM IMPLANT CO.,LTD ONE 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: 2007-12-10
• Decision Date: 2008-04-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800000900063	K073465	000
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