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510(k) K880849

EXAMIX DISPENSER by G-C Intl. Corp. — Product Code EKJ

K880849 is an FDA 510(k) premarket notification submitted by G-C Intl. Corp. for the device "EXAMIX DISPENSER". The FDA issued a decision of Substantially Equivalent on May 11, 1988. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. G-C Intl. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1988
Date Received
March 1, 1988
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 G-C Intl. Corp.

  • K913175 — MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULES (December 27, 1991)
  • K913884 — FUJI II LC (October 30, 1991)
  • K901999 — FUJI LINING CEMENT LIGHT CURE (July 31, 1990)
  • K902531 — EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL (July 13, 1990)
  • K896883 — GC CERVICAL CEMENT (July 6, 1990)
  • K895976 — TOOTH SHADE RESIN (December 22, 1989)
  • K892806 — TUF-COAT (July 14, 1989)
  • K890830 — DENTURE RESIN (May 1, 1989)
  • K890829 — UNIFAST LC (April 17, 1989)
  • K883770 — RESUBMITTED EMA DENTIN CEMENT (November 30, 1988)

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