Product code

QRQ: Non-irrigation endosseous dental implant drill bits

FDA product code · Class I · Dental

Key facts

Product code QRQ
Device Non-irrigation endosseous dental implant drill bits
Device class Class I
Regulation number 872.3980
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 prepare the site for placement of endosseous dental implants. It is to be used at a low speed without irrigation.

At a glance

  • None 510(k) clearances
  • None De Novo grants
  • None PMA approvals
  • None HDE approvals
  • 100–999 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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