Home / 510(k) Clearances / K781605

510(k) K781605

R&R ABSORBENT POINTS by Ransom and Randolph — Product Code EKN

K781605 is an FDA 510(k) premarket notification submitted by Ransom and Randolph for the device "R&R ABSORBENT POINTS". The FDA issued a decision of Substantially Equivalent on October 10, 1978. The device falls under product code EKN (Point, Paper, Endodontic), a Class I device regulated under 21 CFR 872.3830. Ransom and Randolph has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1978
Date Received
September 18, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Point, Paper, Endodontic
Device Class
Class I
Regulation Number
872.3830
Review Panel
DE
Submission Type

Other clearances by Ransom and Randolph

  • K780399 — INSTRUMENT CLEANING BRUSH (March 17, 1978)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K780199 — PROPHY ANGLES, R&R (February 16, 1978)
  • K771347 — R&R ALSTON CARBIDE BURS (August 3, 1977)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)
  • K761067 — DENTSPLY DIE STONE (November 30, 1976)

Other clearances for product code EKN

  • K843017 — ABSORBENT ENDODONTIC POINT (January 9, 1985)
  • K821625 — ENDODONTIC PAPERPOINTS (June 14, 1982)
  • K812886 — ENDODONTIC PAPER POINTS (November 16, 1981)
  • K800827 — PREMIER ABSORBENT POINTS (April 29, 1980)
  • K761203 — ABSORBENT POINTS (December 13, 1976)
  • K760983 — ENDODONTIC INSTRUMENTS (November 15, 1976)

FDA data resources