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510(k) K770367

ROOT CANAL FILES & REAMERS by Cemco Tool Co., Inc. — Product Code EKP

K770367 is an FDA 510(k) premarket notification submitted by Cemco Tool Co., Inc. for the device "ROOT CANAL FILES & REAMERS". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code EKP (Reamer, Pulp Canal, Endodontic), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1977
Date Received
February 22, 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 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)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)

FDA data resources