510(k) Report

510(k) · Cleared

Cleared

Heliomat

K802684510(k) TraditionalCleared Nov 24, 198027-day reviewClass I21 CFR 872.4620

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

Vivadent (Usa), Inc. · EAY Light, Fiber Optic, Dental

Cleared on Nov 24, 1980 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 24, 1980
Review
27 days
Class
Class I
Product code
EAY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K802684Source: 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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  • 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 EAY devices

EAY Light, Fiber Optic, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EAY

FDA has decided no EAY device since 2007.

Median 510(k) review, days · EAY

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

Recalls per year · EAY

No recall names EAY since 2007.

Adverse event reports per year · EAY

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code EAY, 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—01
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 Vivadent (Usa), Inc.

17 FDA decisions under this applicant name. See the company

  • K863831Vivadent FilpinVivadent (Usa), Inc. · 1986
  • K823409Heliosit-OrthodonticVivadent (Usa), Inc. · 1983
  • K813015HeliosealVivadent (Usa), Inc. · 19811 recall
  • K802679SilanitVivadent (Usa), Inc. · 1980
  • K802682Contact SealVivadent (Usa), Inc. · 1980

Recent decisions in EAY

The EAY category page

  • K953191Model A15-101Beaverstate Dental, Inc. · 1995
  • K953192Model A15-103Beaverstate Dental, Inc. · 1995
  • K935718Jedental VLC Dental Curing LightJedental Co., Inc. · 1994
  • K871816Strykerscope TM/Orthoscope TM/Stryker Miniscope TMStryker Corp. · 1987
  • K831976Power OpticRitter Co. · 1983

https://510kreport.com/device/K802684 · printed Nov 4, 2026

Cite this page

510(k) Report. “K802684: Heliomat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K802684

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