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510(k) K812680

G-C IMPRESSION SYRINGE by G-C Intl. Corp. — Product Code EID

K812680 is an FDA 510(k) premarket notification submitted by G-C Intl. Corp. for the device "G-C IMPRESSION SYRINGE". The FDA issued a decision of Substantially Equivalent on October 6, 1981. The device falls under product code EID (Syringe, Restorative And Impression Material), 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
October 6, 1981
Date Received
September 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Restorative And Impression Material
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 EID

  • K941431 — BONE GRAFT DELIVERY SYRINGES (July 12, 1994)
  • K913974 — ACCESS IMPRESSION BARREL (February 25, 1992)
  • K873153 — CAULK'S VPS CARTRIDGE SYSTEM (September 16, 1987)
  • K871937 — IMPRESSION SYRINGE (June 5, 1987)
  • K863998 — COLTENE JET-MIXER (October 30, 1986)
  • K853282 — CENTRIX RIBBON TUBES (August 23, 1985)
  • K851386 — UNITEK DISPOSABLE IMPRESSION SYRINGE (April 29, 1985)
  • K812277 — PRISMA-FIL COMPULES (September 8, 1981)
  • K811582 — THE PLACER (July 28, 1981)
  • K781977 — APPLICATOR, LEE IMPRESSION (December 20, 1978)

FDA data resources