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510(k) K883770

RESUBMITTED EMA DENTIN CEMENT by G-C Intl. Corp. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1988
Date Received
September 6, 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

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  • 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)
  • K880848 — FUJI CAP II CAPSULE & APPLIER (May 16, 1988)

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