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510(k) K880848

FUJI CAP II CAPSULE & APPLIER by G-C Intl. Corp. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1988
Date Received
March 1, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by G-C Intl. Corp.

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  • 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)

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