FDA product code EJQ: Wheel, Polishing Agent

EJQ is the FDA product code for wheel, polishing agent. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under EJQ. The average 510(k) review took 68 days (median 68).

Classification

FieldValue
Device nameWheel, Polishing Agent
Device classClass I
Regulation21 CFR 872.6010
Review panelDE — Dental
Medical specialtyDental
Premarket route510(k) exempt
GMP exemptYes

Compare with all 510(k) review times · Search every EJQ clearance

Top EJQ applicants

ApplicantClearancesLatest
Dentsply Intl.11978-12-20

Most recent EJQ clearances

510(k)ApplicantDeviceDecision dateReview days
K781777Dentsply Intl.ABRASIVE WHEELS1978-12-2068

Recalls for EJQ devices

openFDA lists no recalls for product code EJQ.

Frequently asked questions

What is FDA product code EJQ?

EJQ is the FDA product code for wheel, polishing agent. It is a Class I device, regulated under 21 CFR 872.6010 and reviewed by the Dental panel.

What device class is EJQ?

Class I, regulation 21 CFR 872.6010. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code EJQ?

Across 1 cleared submissions the average was 68 days from receipt to decision (median 68).

Which companies have the most EJQ clearances?

Dentsply Intl. (1).

Next steps

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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