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510(k) K903686

ARGILITE 4 GOLD ALLOY FOR PORCELAIN by Argen Precious Metals, Inc. — Product Code EFT

K903686 is an FDA 510(k) premarket notification submitted by Argen Precious Metals, Inc. for the device "ARGILITE 4 GOLD ALLOY FOR PORCELAIN". The FDA issued a decision of Substantially Equivalent on August 29, 1990. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Argen Precious Metals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1990
Date Received
August 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Denture, Over The Counter
Device Class
Class I
Regulation Number
872.3520
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 EFT

  • K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (May 23, 2008)
  • K051342 — MEDICAL INTERPOROUS (June 2, 2006)
  • K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (June 16, 2000)
  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K930337 — PROFAST(R)-DENTURE CLEANSER (September 7, 1993)
  • K914257 — DENTURE PRODUCT X (January 13, 1993)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K902838 — DENTURE DYNAMIC'S DENTURE MAGIC (September 6, 1990)
  • K895345 — ORAD TOOTHBRUSH CLEANER (March 7, 1990)
  • K890043 — DENTCLEAN CONCENTRATED DENTURE CLEANSER (June 7, 1989)

FDA data resources