S-Clean SQ-SL Implant System Regular

Implant, Endosseous, Root-form

Dentis Co., Ltd.

The following data is part of a premarket notification filed by Dentis Co., Ltd. with the FDA for S-clean Sq-sl Implant System Regular.

Pre-market Notification Details

• Device ID: K192688
• 510k Number: K192688
• Device Name: S-Clean SQ-SL Implant System Regular
• Classification: Implant, Endosseous, Root-form
• Applicant: Dentis Co., Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu, KR 42718
• Contact: Gyu Ri Kim
• Correspondent: April Lee; Withus Group Inc. 106 Superior Irvine, CA 92620
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-26
• Decision Date: 2020-02-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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