J2A Dental Implant System, J2C Dental Implant System

Implant, Endosseous, Root-form

KJ MEDITECH CO., LTD

The following data is part of a premarket notification filed by Kj Meditech Co., Ltd with the FDA for J2a Dental Implant System, J2c Dental Implant System.

Pre-market Notification Details

• Device ID: K150060
• 510k Number: K150060
• Device Name: J2A Dental Implant System, J2C Dental Implant System
• Classification: Implant, Endosseous, Root-form
• Applicant: KJ MEDITECH CO., LTD 959-21 DAECHON-DONG, BUK-GU Gwang-ju, KR 959-21
• Contact: Goong-san Nam
• Correspondent: Priscilla Chung; LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-13
• Decision Date: 2015-04-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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