S-Clean OneQ-SL Narrow Implant System

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 Oneq-sl Narrow Implant System.

Pre-market Notification Details

• Device ID: K161244
• 510k Number: K161244
• Device Name: S-Clean OneQ-SL Narrow Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: Dentis Co., Ltd. 99, Seongseoseo-ro, Dalseo-gu Daegu, KR 42718
• Contact: Sun Chul Shin
• Correspondent: April Lee; Withus Group Inc 2531 Pepperdale Drive Rowland Heights, CA 91748
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-03
• Decision Date: 2016-12-07
• Summary: summary

NIH GUDID Devices

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