FDA product code PYQ: Rfid Chip For Dental Appliance
PYQ is the FDA product code for rfid chip for dental appliance. It is a Class II device, regulated under 21 CFR 880.6300 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under PYQ. The average 510(k) review took 254 days (median 254).
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.
Classification
| Field | Value |
|---|---|
| Device name | Rfid Chip For Dental Appliance |
| Device class | Class II |
| Regulation | 21 CFR 880.6300 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for PYQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 254 |
Compare with all 510(k) review times · Search every PYQ clearance
Top PYQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cmp Industries, LLC | 1 | 2017-10-25 |
Most recent PYQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K170423 | Cmp Industries, LLC | DentureID Microchip | 2017-10-25 | 254 |
Recalls for PYQ devices
openFDA lists no recalls for product code PYQ.
Frequently asked questions
What is FDA product code PYQ?
PYQ is the FDA product code for rfid chip for dental appliance. It is a Class II device, regulated under 21 CFR 880.6300 and reviewed by the General Hospital panel.
What device class is PYQ?
Class II, regulation 21 CFR 880.6300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PYQ?
Across 1 cleared submissions the average was 254 days from receipt to decision (median 254).
Which companies have the most PYQ clearances?
Cmp Industries, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PYQ
- Run a recall and safety report across every PYQ manufacturer
- Watch product code PYQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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