Dentis Dental 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 Dentis Dental Implant System.

Pre-market Notification Details

• Device ID: K150344
• 510k Number: K150344
• Device Name: Dentis Dental Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: DENTIS CO., LTD. 99, SEONGSEOSEO-RO, DALSEO-GU Daegu, KR 704-833
• Contact: Jinju Lee
• Correspondent: April Lee; WithUS Consulting 2531 PEPPEREDALE 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: 2015-02-11
• Decision Date: 2015-07-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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