510(k) K170423
K170423 is an FDA 510(k) premarket notification submitted by Cmp Industries, LLC for the device "DentureID Microchip". The FDA issued a decision of Substantially Equivalent on October 25, 2017. The device falls under product code PYQ (Rfid Chip For Dental Appliance), a Class II device regulated under 21 CFR 880.6300. Cmp Industries, LLC has at least 6 other 510(k) clearances on record.
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.