510(k) Report

510(k) · Cleared

Cleared

Shield, Dental X-Ray, Protective

K770407510(k) TraditionalCleared Mar 15, 197711-day reviewClass I21 CFR 892.6500

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

Worldwide Dental, Inc. · IWO Apron, Protective

Cleared on Mar 15, 1977 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 15, 1977
Review
11 days
Class
Class I
Product code
IWO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770407Source: 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 IWO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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 IWO devices

IWO Apron, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWO

FDA has decided no IWO device since 2007.

Median 510(k) review, days · IWO

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

Recalls per year · IWO

No recall names IWO since 2007.

Adverse event reports per year · IWO

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code IWO, 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—00
20170—01
20180—00
20190—00
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
  • K940785Mouth PropsWorldwide Dental, Inc. · 1994

https://510kreport.com/device/K770407 · printed Nov 4, 2026

Cite this page

510(k) Report. “K770407: Shield, Dental X-Ray, Protective.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K770407

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