510(k) Report

510(k) · Cleared

Cleared

Occlusal Harmony Impression Tray

K884316510(k) TraditionalCleared Dec 22, 198870-day reviewClass I21 CFR 872.6880

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

Advantage Dental Co. · EHY Tray, Impression, Preformed

Cleared on Dec 22, 1988 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 22, 1988
Review
70 days
Class
Class I
Product code
EHY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K884316Source: 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 EHY devices

EHY Tray, Impression, Preformed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EHY

FDA has decided no EHY device since 2007.

Median 510(k) review, days · EHY

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

Recalls per year · EHY

No recall names EHY since 2007.

Adverse event reports per year · EHY

No MAUDE report names EHY since 2007.

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—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in EHY

The EHY category page

  • K942668O-Tray Impression TraysDentauraum, Inc. · 1994
  • K896470Eos Impression TraysIvoclar North America, Inc. · 1990
  • K863836Post TrayMarket Masters, Inc. · 1986
  • K850776Preformed Dental Impression TraysL.A.K. Ent., Inc. · 1985
  • K842274F-G-P TrayDi-Equi Dental Products · 1984

https://510kreport.com/device/K884316 · printed Nov 6, 2026

Cite this page

510(k) Report. “K884316: Occlusal Harmony Impression Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884316

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