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510(k) K890830

DENTURE RESIN by G-C Intl. Corp. — Product Code EBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
February 21, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Denture, Relining, Repairing, Rebasing
Device Class
Class II
Regulation Number
872.3760
Review Panel
DE
Submission Type

Other clearances by G-C Intl. Corp.

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  • 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)
  • K890829 — UNIFAST LC (April 17, 1989)
  • K883770 — RESUBMITTED EMA DENTIN CEMENT (November 30, 1988)
  • K880848 — FUJI CAP II CAPSULE & APPLIER (May 16, 1988)

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