The following data is part of a premarket notification filed by Medimecca Co., Ltd. with the FDA for Hero Ii Dental Implant System, Ui Dental Implant System.
| Device ID | K130221 |
| 510k Number | K130221 |
| Device Name: | HERO II DENTAL IMPLANT SYSTEM, UI DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MEDIMECCA CO., LTD. 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung MEDIMECCA CO., LTD. 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-29 |
| Decision Date | 2013-03-21 |
| Summary: | summary |