510(k) Report

510(k) · Cleared

Cleared

R&R Absorbent Points

K781605510(k) TraditionalCleared Oct 10, 197822-day reviewClass I21 CFR 872.3830

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

Ransom and Randolph · EKN Point, Paper, Endodontic

Cleared on Oct 10, 1978 after a 22-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 10, 1978
Review
22 days
Class
Class I
Product code
EKN
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K781605Source: FDA 510(k) database · 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 EKN? 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 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 EKN devices

EKN Point, Paper, Endodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EKN

FDA has decided no EKN device since 2007.

Median 510(k) review, days · EKN

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

Recalls per year · EKN

No recall names EKN since 2007.

Adverse event reports per year · EKN

No MAUDE report names EKN 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 Ransom and Randolph

7 FDA decisions under this applicant name. See the company

  • K780399Instrument Cleaning BrushRansom and Randolph · 1978
  • K780198Prophy Cups, R&RRansom and Randolph · 1978
  • K780199Prophy Angles, R&RRansom and Randolph · 1978
  • K771347R&R Alston Carbide BursRansom and Randolph · 1977
  • K770598Endodontic Instruments, R&R CutwellRansom and Randolph · 1977

Recent decisions in EKN

The EKN category page

  • K843017Absorbent Endodontic PointUnited Dental Mfg., Inc. · 1985
  • K821625Endodontic PaperpointsRoeko · 1982
  • K812886Endodontic Paper PointsUnited Dental Mfg., Inc. · 1981
  • K800827Premier Absorbent PointsPremier Dental Products Co. · 1980
  • K761203Absorbent PointsJohnson & Johnson Professionals, Inc. · 1976

https://510kreport.com/device/K781605 · printed Nov 4, 2026

Cite this page

510(k) Report. “K781605: R&R Absorbent Points.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K781605

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
  • Page last updated Nov 3, 2026