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510(k) K922988

ECO/DENTAL GENERAL DENTAL PACK by Dyna-Pace Systems, Inc. — Product Code EKJ

K922988 is an FDA 510(k) premarket notification submitted by Dyna-Pace Systems, Inc. for the device "ECO/DENTAL GENERAL DENTAL PACK". The FDA issued a decision of Substantially Equivalent on November 4, 1992. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1992
Date Received
June 22, 1992
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 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)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)

FDA data resources