510(k) Report

510(k) · Cleared

Cleared

Prophylaxis Cup.

K803155510(k) TraditionalCleared Jan 8, 198127-day reviewClass I21 CFR 872.6290

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

Teledyne Densco · EHK Cup, Prophylaxis

Cleared on Jan 8, 1981 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 8, 1981
Review
27 days
Class
Class I
Product code
EHK
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K803155Source: 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 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 EHK devices

EHK Cup, Prophylaxis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EHK

FDA has decided no EHK device since 2007.

Median 510(k) review, days · EHK

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

Recalls per year · EHK

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EHK

1in 2022

2016: 12022: 1
2007high 1 (2016) · low 0 (2007)2025

MAUDE reports naming product code EHK, 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—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—10
20240—00
20250—00
20260—0—

More from Teledyne Densco

4 FDA decisions under this applicant name. See the company

  • K821686Densco Prophy AngleTeledyne Densco · 1982
  • K821364Proflex Flexible ScalerTeledyne Densco · 1982
  • K780641Dental Rotary Carbide Burs 76EJLTeledyne Densco · 1978

Recent decisions in EHK

The EHK category page

  • K953628Prophy AngleRolence Enterprise Co., Ltd. · 1995
  • K951016Disposable Prophylaxis AnglePreventive Technologies, Inc. · 1995
  • K900507Disposable Screw Type Prophy BrushDentsply Intl. · 1990
  • K864059Dental Prophy Cups (Various Types)Mission White Dental, Inc. · 1986
  • K790723Prophylaxis Cups and PolishersYoung Dental Manufacturing Co. 1, LLC · 1979

https://510kreport.com/device/K803155 · printed Nov 4, 2026

Cite this page

510(k) Report. “K803155: Prophylaxis Cup..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K803155

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