510(k) Report

510(k) · Cleared

Cleared

Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks with Microdent/Reach Floss Pics with Microdent Etc.

K963747510(k) TraditionalCleared Dec 16, 199690-day reviewClass I21 CFR 872.6650

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

Whitehill Manufacturing, Inc. · JET Pick, Massaging

Cleared on Dec 16, 1996 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Dec 16, 1996
Review
90 days
Class
Class I
Product code
JET
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared1995200020052010201520202025
  1. This deviceK963747 Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks…Whitehill Manufacturing, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK070127 Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model…Kevin Vu, Dds · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K070127Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02Kevin Vu, Dds · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K963747Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks with…Whitehill Manufacturing, Inc.1996—
+1K070127Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02Kevin Vu, Dds2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K963747, 1996–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 JET? 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
Get a 510(k) Report

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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070127Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02Kevin Vu, Dds20070

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.

What does this lineage say?

  • Of its descendants, K070127 (Kevin Vu, Dds, 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JET devices

JET Pick, Massaging: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JET

FDA has decided no JET device since 2007.

Median 510(k) review, days · JET

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

Recalls per year · JET

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JET

11in 2025

2008: 22009: 12011: 12013: 12016: 12018: 12021: 22022: 392023: 172024: 122025: 11
2007high 39 (2022) · low 0 (2007)2025

MAUDE reports naming product code JET, 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—02
20090—01
20100—00
20110—01
20120—00
20130—01
20140—00
20150—00
20160—01
20170—00
20180—01
20190—00
20200—00
20210—02
20220—139
20230—017
20240—012
20250—011
20260—0—

Recent decisions in JET

The JET category page

  • K942633Oral-B Interdental Woodsticks with FluorideOral-B Laboratories · 1995
  • K930178Electro FlossArizona Implant Dentistry · 1993
  • K911418Gum MassagerBurn-Henderson Partnership · 1991
  • K885189Massaging Pick for Oral HygieneDentek Corp. · 1989
  • K890910PlakofXimex, Ltd. · 1989

https://510kreport.com/device/K963747 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963747: Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks with Microdent/Reach Floss Pics with Microdent Etc..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963747

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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