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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 Jan 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
Jan 19, 2022
Date Received
Oct 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
510(k)

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  • K162043 — NobelProcera HT ML FCZ Bridge (Nov 22, 2016)
  • K153534 — NobelProcera HT ML Full Contour Zirconia Crown (Jun 6, 2016)
  • K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013 (Jul 11, 2007)
  • K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING… (May 22, 2006)
  • K041283 — PROCERA BRIDGE ZIRCONIA (May 28, 2004)
  • K032562 — PROCEARA COPINGS AND PONTIC (Feb 6, 2004)
  • K965216 — ARGI-SATIN OR OPTI0-STAR (Feb 27, 1997)
  • K960770 — MATCHMAKER/PROPAQUE PORCELAIN (Nov 19, 1996)
  • K960480 — IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013 (Mar 15, 1996)

FDA data resources