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510(k) K954358

ARGENDENT GIO 86 FR by Argen Precious Metals, Inc. — Product Code EJT

K954358 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "ARGENDENT GIO 86 FR". The FDA issued a decision of Substantially Equivalent on Oct 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 216 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 7, 1995
Date Received
Sep 18, 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
510(k) Exempt

Other clearances by Argen Precious Metals, Inc.

  • K965216 — ARGI-SATIN OR OPTI0-STAR (Feb 27, 1997)
  • K961352 — 285 SL (May 20, 1996)
  • K961211 — ARGELITE 52+ (Apr 25, 1996)
  • K961285 — ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) (Apr 18, 1996)
  • K954362 — ARGISTAR 74 (Oct 12, 1995)
  • K954359 — SILFREE 80SF+ (Oct 7, 1995)
  • K954361 — ARGENCO 68M (Oct 7, 1995)
  • K954404 — AUROLITE 45 (Oct 7, 1995)
  • K954371 — SUREFIRE S (Oct 7, 1995)
  • K954367 — ARGISTAR BIO 75PF (Oct 7, 1995)

Other clearances for product code EJT

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

FDA data resources