US 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 System.

Pre-market Notification Details

• Device ID: K062030
• 510k Number: K062030
• Device Name: US SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: OSSTEM IMPLANT CO.,LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338
• Contact: Cathryn N Cambria
• Correspondent: Cathryn N Cambria; OSSTEM IMPLANT CO.,LTD 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-07-18
• Decision Date: 2006-11-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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