Product code

PYQ: Rfid chip for dental appliance

FDA product code · Class II · General Hospital

Key facts

Product code PYQ
Device Rfid chip for dental appliance
Device class Class II
Regulation number 880.6300
Review panel General Hospital
Medical specialty General Hospital
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
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.

At a glance

  • 1–9 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 1–9 UDI devices (GUDID)
  • 1–9 MAUDE adverse event reports
  • None Recalled products (Z-numbers)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device product codes

FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.

Source: U.S. Food and Drug Administration (FDA), Product Classification database

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