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510(k) K950894

SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) by Argen Precious Metals, Inc. — Product Code EJH

K950894 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS)". The FDA issued a decision of Substantially Equivalent on March 31, 1995. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Argen Precious Metals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
February 27, 1995
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 Argen Precious Metals, Inc.

  • K965216 — ARGI-SATIN OR OPTI0-STAR (February 27, 1997)
  • K961352 — 285 SL (May 20, 1996)
  • K961211 — ARGELITE 52+ (April 25, 1996)
  • K961285 — ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) (April 18, 1996)
  • K954362 — ARGISTAR 74 (October 12, 1995)
  • K954358 — ARGENDENT GIO 86 FR (October 7, 1995)
  • K954361 — ARGENCO 68M (October 7, 1995)
  • K954404 — AUROLITE 45 (October 7, 1995)
  • K954371 — SUREFIRE S (October 7, 1995)
  • K954367 — ARGISTAR BIO 75PF (October 7, 1995)

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