The following data is part of a premarket notification filed by Intai Technology Corp. with the FDA for Royal-dent Eureka Dental Implant System.
| Device ID | K122804 |
| 510k Number | K122804 |
| Device Name: | ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTAI TECHNOLOGY CORP. 9 JINGKE ROAD, NANTUN DISTRICT Taichung City, TW 40852 |
| Contact | Kevin Wang |
| Correspondent | Kevin Wang INTAI TECHNOLOGY CORP. 9 JINGKE ROAD, NANTUN DISTRICT Taichung City, TW 40852 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-13 |
| Decision Date | 2013-05-20 |
| Summary: | summary |