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510(k) K770598

ENDODONTIC INSTRUMENTS, R&R CUTWELL by Ransom and Randolph — Product Code EKP

K770598 is an FDA 510(k) premarket notification submitted by Ransom and Randolph for the device "ENDODONTIC INSTRUMENTS, R&R CUTWELL". The FDA issued a decision of Substantially Equivalent on April 5, 1977. The device falls under product code EKP (Reamer, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565. Ransom and Randolph has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1977
Date Received
March 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reamer, Pulp Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Ransom and Randolph

  • K781605 — R&R ABSORBENT POINTS (October 10, 1978)
  • K780399 — INSTRUMENT CLEANING BRUSH (March 17, 1978)
  • K780199 — PROPHY ANGLES, R&R (February 16, 1978)
  • K780198 — PROPHY CUPS, R&R (February 16, 1978)
  • K771347 — R&R ALSTON CARBIDE BURS (August 3, 1977)
  • K761067 — DENTSPLY DIE STONE (November 30, 1976)

Other clearances for product code EKP

  • K823686 — REAMER TYPE K ENDODONTIC (December 28, 1982)
  • K822620 — ROOT CANAL REAMERS, TYPE K (September 28, 1982)
  • K800291 — ENDEX REAMERS PULP CANAL, ENDODONTIC (February 19, 1980)
  • K770331 — DIALYSIS, JET SYSTEM (April 20, 1977)
  • K770367 — ROOT CANAL FILES & REAMERS (March 1, 1977)

FDA data resources