510(k) K170423
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 25, 2017
- Date Received
- February 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rfid Chip For Dental Appliance
- Device Class
- Class II
- Regulation Number
- 880.6300
- Review Panel
- HO
- Submission Type
The device is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures, and other removable oral appliances.