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510(k) K854495

GRESCO N.P. DENTAL ALLOY by Gresco Products, Inc. — Product Code EJH

K854495 is an FDA 510(k) premarket notification submitted by Gresco Products, Inc. for the device "GRESCO N.P. DENTAL ALLOY". The FDA issued a decision of Substantially Equivalent on December 27, 1985. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Gresco Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
November 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by Gresco Products, Inc.

  • K981524 — PRILANE (July 10, 1998)
  • K913405 — KAR-D-TEK (October 28, 1991)
  • K910813 — MET-ETCH (May 7, 1991)
  • K910803 — ENAMEL ETCHING GEL (March 15, 1991)
  • K901973 — CP-3 DENTAL POLISHING MATERIAL (June 1, 1990)
  • K854494 — CERAM-ETCH (December 23, 1985)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources