510(k) Report

510(k) · Cleared

Cleared

Abrasive Wheels

K781777510(k) TraditionalCleared Dec 20, 197868-day reviewClass I21 CFR 872.6010

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dentsply Intl. · EJQ Wheel, Polishing Agent

Cleared on Dec 20, 1978 after a 68-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 20, 1978
Review
68 days
Class
Class I
Product code
EJQ
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K781777Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EJQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EJQ devices

EJQ Wheel, Polishing Agent: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EJQ

FDA has decided no EJQ device since 2007.

Median 510(k) review, days · EJQ

Too few EJQ 510(k)s in any year since 2007 to give a median.

Recalls per year · EJQ

No recall names EJQ since 2007.

Adverse event reports per year · EJQ

1in 2022

2016: 12022: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code EJQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Dentsply Intl.

279 FDA decisions under this applicant name. See the company

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  • K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl. · 2008
  • K070538XP Bond Dual Cure Universal Total Etch AdhesiveDentsply Intl. · 2007
  • K070019Carrara VolumiaDentsply Intl. · 2007
  • K061427Pre-Impression Conditioning SolutionDentsply Intl. · 2006

https://510kreport.com/device/K781777 · printed Nov 6, 2026

Cite this page

510(k) Report. “K781777: Abrasive Wheels.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K781777

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026