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510(k) K910569

TYCERAMIC by Jeneric/Pentron, Inc. — Product Code ELL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1991
Date Received
February 11, 1991
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

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  • K012231 — AVANTE MICRO CRYSTAL SYSTEM (August 23, 2001)
  • K011748 — FIRST FILL R.C.S. (August 3, 2001)
  • K010957 — QUELL DESENSITIZER (June 25, 2001)
  • K011330 — JP CAST 50 (June 22, 2001)
  • K011331 — JP CAST 40 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)

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  • 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)
  • K965216 — ARGI-SATIN OR OPTI0-STAR (February 27, 1997)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (November 19, 1996)