Product code

QIA: Powered tongue scraper

FDA product code · Class I · Dental

Key facts

Product code QIA
Device Powered tongue scraper
Device class Class I
Regulation number 872.6865
Review panel Dental
Medical specialty Dental
Submission type 510(K) Exempt
GMP exempt No
Implanted device No
Life-sustaining or life-supporting No
Definition The device is intended to remove debris from the top surface of the tongue as a supplement to normal daily oral hygiene care.

At a glance

  • 1–9 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • None UDI devices (GUDID)
  • None 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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