DeviceClearance

Product code PYQ— General Hospital

DentureID Microchip

Classification name
Rfid Chip For Dental Appliance
Device class
Class 2
Regulation
21 CFR 880.6300
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PYQ under 21 CFR 880.6300, via openFDA

Market context for product code PYQ

FDA has cleared 1 device under product code PYQ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PYQ

Recent clearances under product code PYQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.