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510(k) K901999

FUJI LINING CEMENT LIGHT CURE by G-C Intl. Corp. — Product Code EJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1990
Date Received
May 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Liner, Cavity, Calcium Hydroxide
Device Class
Class II
Regulation Number
872.3250
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)
  • 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)
  • K880848 — FUJI CAP II CAPSULE & APPLIER (May 16, 1988)

Other clearances for product code EJK

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  • K230270 — 3M™ VitCal Liner/Base (February 6, 2023)
  • K212475 — Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) (May 13, 2022)
  • K201799 — CleaniCal (February 12, 2021)
  • K202413 — LC ResinCal PC (November 20, 2020)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K180344 — TheraCal DC (April 5, 2018)
  • K143292 — TheraCal DC (August 4, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K141047 — LC CALCIUMHYDROXIDE LINER (April 14, 2015)