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510(k) K943351

MAUNAL DISPOSABLE DENTAL INSTRUMENTS by Magnum Instruments, Inc. — Product Code EKJ

K943351 is an FDA 510(k) premarket notification submitted by Magnum Instruments, Inc. for the device "MAUNAL DISPOSABLE DENTAL INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on October 7, 1994. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Magnum Instruments, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1994
Date Received
July 12, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Magnum Instruments, Inc.

  • K943820 — STAT PAK (November 2, 1994)

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)
  • K925115 — AMD DENTIST AND HYGIENIST KITS (July 5, 1994)

FDA data resources