Home / 510(k) Clearances / K965216

510(k) K965216

ARGI-SATIN OR OPTI0-STAR by Argen Precious Metals, Inc. — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1997
Date Received
December 30, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Teeth, Porcelain
Device Class
Class II
Regulation Number
872.3920
Review Panel
DE
Submission Type

Other clearances by Argen Precious Metals, Inc.

  • 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)
  • K954360 — ARGESOL 600 (October 7, 1995)
  • K954371 — SUREFIRE S (October 7, 1995)
  • K954367 — ARGISTAR BIO 75PF (October 7, 1995)
  • K954358 — ARGENDENT GIO 86 FR (October 7, 1995)
  • K954404 — AUROLITE 45 (October 7, 1995)
  • K954361 — ARGENCO 68M (October 7, 1995)

Other clearances for product code ELL

  • K240586 — Additive Manufacturing Zirconia Customized Restoration (October 3, 2024)
  • K203072 — Franz Zirconia Dental Crown (January 19, 2022)
  • K162043 — NobelProcera HT ML FCZ Bridge (November 22, 2016)
  • K153534 — NobelProcera HT ML Full Contour Zirconia Crown (June 6, 2016)
  • K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (July 11, 2007)
  • K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING F (May 22, 2006)
  • K041283 — PROCERA BRIDGE ZIRCONIA (May 28, 2004)
  • K032562 — PROCEARA COPINGS AND PONTIC (February 6, 2004)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)
  • K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (March 15, 1996)