SIMPLELINE II ABUTMENT SYSTEM

Abutment, Implant, Dental, Endosseous

DENTIUM CO., LTD.

The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Simpleline Ii Abutment System.

Pre-market Notification Details

• Device ID: K112045
• 510k Number: K112045
• Device Name: SIMPLELINE II ABUTMENT SYSTEM
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: DENTIUM CO., LTD. 27-5 LEUI-DONG, YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 442-270
• Contact: Jonghyun Choi
• Correspondent: Jonghyun Choi; DENTIUM CO., LTD. 27-5 LEUI-DONG, YEONGTONG-GU Suwon-si, Gyeonggi-do, KR 442-270
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-18
• Decision Date: 2012-01-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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