510(k) Report

510(k) · Cleared

Cleared

Fixtector

K864572510(k) TraditionalCleared Feb 12, 198784-day reviewClass I21 CFR 872.6140

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

Prodent Intl., Inc. · EFH Paper, Articulation

Cleared on Feb 12, 1987 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 12, 1987
Review
84 days
Class
Class I
Product code
EFH
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K864572Source: 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 EFH? 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
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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 EFH devices

EFH Paper, Articulation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EFH

FDA has decided no EFH device since 2007.

Median 510(k) review, days · EFH

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

Recalls per year · EFH

No recall names EFH since 2007.

Adverse event reports per year · EFH

1in 2015

2011: 12012: 12014: 12015: 1
2007high 1 (2011) · low 0 (2007)2025

MAUDE reports naming product code EFH, 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—01
20120—01
20130—00
20140—01
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Prodent Intl., Inc.

2 FDA decisions under this applicant name. See the company

  • K904296Lysta Hygienist Iii ScalerProdent Intl., Inc. · 1990

Recent decisions in EFH

The EFH category page

  • K965026Pfingst Pressure PastePfingst & Co., Inc. · 1997
  • K912632OccludePascal Co., Inc. · 1992
  • K911259HydentPascal Co., Inc. · 1991
  • K870032Revised T-Scan SystemSentek, Inc. · 1987
  • K832647Articulating PaperArdent Intl., Inc. · 1984

https://510kreport.com/device/K864572 · printed Nov 4, 2026

Cite this page

510(k) Report. “K864572: Fixtector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K864572

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