SuperLine

Implant, Endosseous, Root-form

Dentium Co., Ltd.

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

Pre-market Notification Details

• Device ID: K213599
• 510k Number: K213599
• Device Name: SuperLine
• Classification: Implant, Endosseous, Root-form
• Applicant: Dentium Co., Ltd. 76, Changnyong-daero 256beon-gil Suwon-si, KR 16229
• Contact: Eunsang Lee
• Correspondent: Kevin A Thomas; PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-11-15
• Decision Date: 2022-02-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D755FXS7007C0	K213599	000
D755FXS3607C0	K213599	000
D755FXS4007BC0	K213599	000
D755FXS4007C0	K213599	000
D755FXS4507BC0	K213599	000
D755FXS4507C0	K213599	000
D755FXS5007BC0	K213599	000
D755FXS5007C0	K213599	000
D755FXS6007C0	K213599	000
D755FXS3607BC0	K213599	000