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: K160965
• 510k Number: K160965
• Device Name: SuperLine
• Classification: Implant, Endosseous, Root-form
• Applicant: DENTIUM CO., LTD. 29 TEHERAN-RO, 87-GZL GANGNAM-GU Seoul, KR 446-518
• Contact: Younjung Yuk
• Correspondent: Claude Berthoin; DENTEPRISE INTERNATIONAL, INC. / 510K FDA CONSULTING 100 EAST GRANADA BLVD. SUITE 219 Ormond Beach, FL 32176
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-06
• Decision Date: 2017-01-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08809740719836	K160965	000
08809740719638	K160965	000
08809740719621	K160965	000
08809740719614	K160965	000
08809740719607	K160965	000
08809740719577	K160965	000
08809740719560	K160965	000
08809740719553	K160965	000
08809740719546	K160965	000
08809740719539	K160965	000
08809740719508	K160965	000
08809740719492	K160965	000
08809740719485	K160965	000
08809740719478	K160965	000
08809740719645	K160965	000
08809740719676	K160965	000
08809740719829	K160965	000
08809740719812	K160965	000
08809740719805	K160965	000
08809740719799	K160965	000
08809740719775	K160965	000
08809740719768	K160965	000
08809740719751	K160965	000
08809740719744	K160965	000
08809740719737	K160965	000
08809740719713	K160965	000
08809740719706	K160965	000
08809740719690	K160965	000
08809740719683	K160965	000
08809740719461	K160965	000