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510(k) K910569

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

K910569 is an FDA 510(k) premarket notification submitted by Jeneric/Pentron, Inc. for the device "TYCERAMIC". The FDA issued a decision of Substantially Equivalent on April 15, 1991. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Jeneric/Pentron, Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Jeneric/Pentron, Inc.

  • K020499 — BOND-3 ADHESIVE (April 22, 2002)
  • K013543 — BOND-1 C & B (February 22, 2002)
  • K013542 — DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) (February 14, 2002)
  • K012231 — AVANTE MICRO CRYSTAL SYSTEM (August 23, 2001)
  • K011748 — FIRST FILL R.C.S. (August 3, 2001)
  • K010957 — QUELL DESENSITIZER (June 25, 2001)
  • K011331 — JP CAST 40 (June 22, 2001)
  • K011330 — JP CAST 50 (June 22, 2001)
  • K011362 — GOLD CORE 73 LS (May 29, 2001)
  • K010044 — COSMIC (February 9, 2001)

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

FDA data resources