Rfid Chip For Dental Appliance
The RFID Chip for Dental Appliance is a small radio frequency identification chip intended to be embedded in complete dentures, partial dentures, and other removable oral appliances to enable access to secure patient identification and device information. It is classified as a Class 2 device under regulation 880.6300, meaning it requires 510(k) premarket notification or a De Novo request to demonstrate substantial equivalence before marketing. The product code is PYQ, and it falls within the General Hospital (HO) medical specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PYQ
- Device Class
- FDA class 2
- Regulation Number
- 880.6300
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K170423 | DentureID Microchip | Oct 25, 2017 | Substantially Equivalent | Cmp Industries, LLC |