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510(k) K203072

Franz Zirconia Dental Crown by Franz Biotech, Inc. — Product Code ELL

K203072 is an FDA 510(k) premarket notification submitted by Franz Biotech, Inc. for the device "Franz Zirconia Dental Crown". The FDA issued a decision of Substantially Equivalent on January 19, 2022. The device falls under product code ELL (Teeth, Porcelain), a Class II device regulated under 21 CFR 872.3920.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2022
Date Received
October 9, 2020
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 for product code ELL

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  • 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)
  • K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (March 15, 1996)

FDA data resources