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510(k) K960480

IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 by Vident — Product Code ELL

K960480 is an FDA 510(k) premarket notification submitted by Vident for the device "IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013". The FDA issued a decision of Substantially Equivalent on March 15, 1996. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920. Vident has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1996
Date Received
February 2, 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 Vident

  • K063768 — TITANIUM SCALLOPED ABUTMENT (June 27, 2007)
  • K060441 — VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX6 (April 27, 2006)
  • K052710 — VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 (January 13, 2006)
  • K052130 — VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 (August 15, 2005)
  • K050362 — VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) (March 15, 2005)
  • K022996 — VITA IN-CERAM YZ CUBES FOR CEREC (October 9, 2002)
  • K012473 — VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT (September 11, 2002)
  • K000597 — VITA RESPONSE (May 17, 2000)
  • K990367 — PDQ AND PDQ-TI ABUTMENT (April 21, 1999)
  • K984198 — WIDE BODY ABUTMENTS (February 18, 1999)

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