510(k) Premarket Notification

• Device Classification Name: implant, endosseous, root-form
• 510(K) Number: K121047
• Device Name: HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
• Applicant: KJ MEDITECH CO., LTD; 951 starbuck st.; unit j; fullerton, CA 92833
• Contact: priscilla chung
• Regulation Number: 872.3640
• Classification Product Code: DZE
• Subsequent Product Code: NHA
• Date Received: 04/06/2012
• Decision Date: 10/04/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Dental
• Review Advisory Committee: Dental
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No