510(k) Report

510(k) · Cleared

Cleared

O-Tray Impression Trays

K942668510(k) TraditionalCleared Jul 22, 199446-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

Dentauraum, Inc. · EHY Tray, Impression, Preformed

Cleared on Jul 22, 1994 after a 46-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 22, 1994
Review
46 days
Class
Class I
Product code
EHY
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 K942668Source: 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 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—

More from Dentauraum, Inc.

24 FDA decisions under this applicant name. See the company

  • K952866Rematitan TitaniumDentauraum, Inc. · 1995
  • K952870Remanium: CS & G-SoftDentauraum, Inc. · 1995
  • K952867Remanium:GM 700, GM 380, GM 800, GFHDentauraum, Inc. · 1995
  • K952865Remanium: 200,CS, 380, and CDDentauraum, Inc. · 1995
  • K952868Dentaurum Jacket Crown & Root PostsDentauraum, Inc. · 1995

Recent decisions in EHY

The EHY category page

  • K896470Eos Impression TraysIvoclar North America, Inc. · 1990
  • K884316Occlusal Harmony Impression TrayAdvantage Dental Co. · 1988
  • K863836Post TrayMarket Masters, Inc. · 1986
  • K850776Preformed Dental Impression TraysL.A.K. Ent., Inc. · 1985
  • K842273Crown Index TrayDi-Equi Dental Products · 1984

https://510kreport.com/device/K942668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942668: O-Tray Impression Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942668

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