510(k) Report

510(k) · Cleared

Cleared

Mouth Props

K940785510(k) TraditionalCleared Oct 5, 1994225-day reviewClass I21 CFR 872.4565

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

Worldwide Dental, Inc. · EIF Accessories, Retractor, Dental

Cleared on Oct 5, 1994 after a 225-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Oct 5, 1994
Review
225 days
Class
Class I
Product code
EIF
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K940785Source: 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.

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 EIF devices

EIF Accessories, Retractor, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EIF

FDA has decided no EIF device since 2007.

Median 510(k) review, days · EIF

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

Recalls per year · EIF

No recall names EIF since 2007.

Adverse event reports per year · EIF

2in 2019

2012: 12014: 22015: 82016: 12017: 12019: 2
2007high 8 (2015) · low 0 (2007)2025

MAUDE reports naming product code EIF, 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—01
20130—00
20140—02
20150—08
20160—01
20170—01
20180—00
20190—02
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Worldwide Dental, Inc.

4 FDA decisions under this applicant name. See the company

  • K961472Dental Dam SiliconeWorldwide Dental, Inc. · 1996
  • K945077Instrument,Filling,Plastic,DentalWorldwide Dental, Inc. · 1994
  • K770407Shield, Dental X-Ray, ProtectiveWorldwide Dental, Inc. · 1977

Recent decisions in EIF

The EIF category page

  • K873960Lewis Safe SleeveCheri Lewis, D.D.S. · 1987
  • K830187Focus FluidHematology Marketing Assoc. · 1983
  • K830116SulcaringsNorth Pacific Dental, Inc. · 1983

https://510kreport.com/device/K940785 · printed Nov 4, 2026

Cite this page

510(k) Report. “K940785: Mouth Props.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K940785

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