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510(k) K954404

AUROLITE 45 by Argen Precious Metals, Inc. — Product Code EJT

K954404 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "AUROLITE 45". The FDA issued a decision of Substantially Equivalent on October 7, 1995. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Argen Precious Metals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1995
Date Received
September 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
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)
  • K954361 — ARGENCO 68M (October 7, 1995)
  • K954358 — ARGENDENT GIO 86 FR (October 7, 1995)
  • K954360 — ARGESOL 600 (October 7, 1995)
  • K954359 — SILFREE 80SF+ (October 7, 1995)
  • K954367 — ARGISTAR BIO 75PF (October 7, 1995)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources