510(k) K122804
K122804 is an FDA 510(k) premarket notification submitted by Intai Technology Corp. for the device "ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on May 20, 2013. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Intai Technology Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 20, 2013
- Date Received
- Sep 13, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)