Scan Abutments And Comfort Caps

Abutment, Implant, Dental, Endosseous

Dentium Co., Ltd.

The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Scan Abutments And Comfort Caps.

Pre-market Notification Details

• Device ID: K191634
• 510k Number: K191634
• Device Name: Scan Abutments And Comfort Caps
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, KR 446-914
• Contact: Byung-sun Kim
• Correspondent: Byung-sun Kim; Dentium Co., Ltd. 150, Eondong-ro, Giheung-gu Yongin-si, KR 446-914
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-06-19
• Decision Date: 2019-11-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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