Franz Zirconia Dental Crown— 510(k) K203072

Name: FDA 510(k) clearance K203072
Creator: U.S. Food and Drug Administration
Published: 2022-01-19

Substantially Equivalent

Franz Biotech, Inc.

FDA 510(k) clearance K203072 for Franz Zirconia Dental Crown, Substantially Equivalent on 2022-01-19. Applicant: Franz Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Franz Biotech, Inc.
Product code: Code ELL
Device class: Class 2
Regulation: 21 CFR 872.3920
Advisory panel: Dental
Date received: 2020-10-09
Decision date: 2022-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei City, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELL

view all

K240586 — Additive Manufacturing Zirconia Customized Restoration2024-10-03
K162043 — NobelProcera HT ML FCZ Bridge2016-11-22
K153534 — NobelProcera HT ML Full Contour Zirconia Crown2016-06-06
K071182 — PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-40132007-07-11
K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.2006-05-22

Data sourced from openFDA. This site is unofficial and independent of the FDA.