510(k) Report

510(k) · Cleared

Cleared

Kwix-Bite X-Ray Film Holder

K801079510(k) TraditionalCleared May 20, 198013-day reviewClass I21 CFR 872.1905

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

Henry Schein, Inc. · EGZ Holder, Film, X-Ray

Cleared on May 20, 1980 after a 13-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 20, 1980
Review
13 days
Class
Class I
Product code
EGZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K801079Source: 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 EGZ? 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 EGZ devices

EGZ Holder, Film, X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EGZ

FDA has decided no EGZ device since 2007.

Median 510(k) review, days · EGZ

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

Recalls per year · EGZ

No recall names EGZ since 2007.

Adverse event reports per year · EGZ

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code EGZ, 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—01
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Henry Schein, Inc.

8 FDA decisions under this applicant name. See the company

  • K041580ImagerayiHenry Schein, Inc. · 2004
  • K862384Schein AP-1 Air Polishing UnitHenry Schein, Inc. · 1986
  • K862385Schein Bleaching UnitHenry Schein, Inc. · 1986
  • K841199Fiberglass Mouth MirrorsHenry Schein, Inc. · 1984
  • K834055Vanadium Excavators Sizes 0-6Henry Schein, Inc. · 19848 recalls

Recent decisions in EGZ

The EGZ category page

  • K913168SalibagNix Co., Ltd. · 1991
  • K913160ID-TABNix Co., Ltd. · 1991
  • K890355Dental X-Ray Bite BlockBite-A-Block · 1989
  • K853451Troll-BiteTrollplast, Inc. · 1986
  • K852170Ezx Yellow, Blue or OrangeStrong Marketing · 1985

https://510kreport.com/device/K801079 · printed Nov 6, 2026

Cite this page

510(k) Report. “K801079: Kwix-Bite X-Ray Film Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K801079

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