HERO II DENTAL IMPLANT SYSTEM, IS 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 Hero Ii Dental Implant System, Is Dental Implant System.

Pre-market Notification Details

• Device ID: K121047
• 510k Number: K121047
• Device Name: HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
• Classification: Implant, Endosseous, Root-form
• Applicant: KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833
• Contact: Priscilla Chung
• Correspondent: Priscilla Chung; KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-04-06
• Decision Date: 2012-10-04
• Summary: summary

NIH GUDID Devices

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