HS/HG PROSTHETIC SYSTEM

Abutment, Implant, Dental, Endosseous

OSSTEM IMPLANT CO.,LTD

The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Hs/hg Prosthetic System.

Pre-market Notification Details

• Device ID: K100245
• 510k Number: K100245
• Device Name: HS/HG PROSTHETIC SYSTEM
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030
• Contact: Patrick Lim
• Correspondent: Patrick Lim; OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-27
• Decision Date: 2010-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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08800000915814	K100245	000
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