Kisses Mini

Implant, Endosseous, Root-form

ACHIMHAI Medical Corporation

The following data is part of a premarket notification filed by Achimhai Medical Corporation with the FDA for Kisses Mini.

Pre-market Notification Details

• Device ID: K170394
• 510k Number: K170394
• Device Name: Kisses Mini
• Classification: Implant, Endosseous, Root-form
• Applicant: ACHIMHAI Medical Corporation 28, Namyang-ro, 930beon-gil, Namyang-eup Hwaseong-si, KR 18255
• Contact: Ji Ho Jung
• Correspondent: Priscilla Chung; LK Consulting Group USA, Inc. 800 Roosevelt STE 417 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: 2017-02-08
• Decision Date: 2017-10-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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