Home / 510(k) Clearances / K904467

510(k) K904467

ARGILITE 3 by Argen Precious Metals, Inc. — Product Code EIT

K904467 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "ARGILITE 3". The FDA issued a decision of Substantially Equivalent on October 31, 1990. The device falls under product code EIT (Applicator, Rapid Wax, Dental), 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 31, 1990
Date Received
October 1, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Applicator, Rapid Wax, Dental
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)

FDA data resources