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510(k) K770331

DIALYSIS, JET SYSTEM by Janneck Ent. of Texas — Product Code EKP

K770331 is an FDA 510(k) premarket notification submitted by Janneck Ent. of Texas for the device "DIALYSIS, JET SYSTEM". The FDA issued a decision of Substantially Equivalent on April 20, 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
April 20, 1977
Date Received
February 17, 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)
  • K770598 — ENDODONTIC INSTRUMENTS, R&R CUTWELL (April 5, 1977)
  • K770367 — ROOT CANAL FILES & REAMERS (March 1, 1977)

FDA data resources