510(k) Report

510(k) · Cleared

Cleared

Pinidentoflex Dental Polisher

K780377510(k) TraditionalCleared Mar 14, 19786-day reviewClass I21 CFR 872.6010

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

Cavitron Corp. · EHL Point, Abrasive

Cleared on Mar 14, 1978 after a 6-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 14, 1978
Review
6 days
Class
Class I
Product code
EHL
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780377Source: 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 EHL? 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 EHL devices

EHL Point, Abrasive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EHL

FDA has decided no EHL device since 2007.

Median 510(k) review, days · EHL

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

Recalls per year · EHL

No recall names EHL since 2007.

Adverse event reports per year · EHL

1in 2024

2014: 12016: 12023: 22024: 1
2007high 2 (2023) · low 0 (2007)2025

MAUDE reports naming product code EHL, 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—01
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—02
20240—01
20250—00
20260—0—

More from Cavitron Corp.

32 FDA decisions under this applicant name. See the company

  • K811582The PlacerCavitron Corp. · 1981
  • K810207Minor Surgery LightCavitron Corp. · 1981
  • K802928Spirometric Computer #SC-10Cavitron Corp. · 1980
  • K801623Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
  • K801877Slit Lamp AttachmentCavitron Corp. · 1980

Recent decisions in EHL

The EHL category page

  • K792250Cutter PointsCutter Laboratories, Inc. · 1980
  • K780811Dental Abrasive DeviceCavitron Corp. · 1978
  • K780376Minidentoflex New Polishing SystemCavitron Corp. · 1978

https://510kreport.com/device/K780377 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780377: Pinidentoflex Dental Polisher.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780377

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