Cleared Traditional

K203072 - Franz Zirconia Dental Crown

K203072 is an FDA 510(k) clearance for Franz Zirconia Dental Crown, manufactured by Franz Biotech, Inc.. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 467-day FDA review.

K203072 · Franz Biotech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
467d
Days
Class 2
Risk

K203072 is an FDA 510(k) clearance for the Franz Zirconia Dental Crown. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Franz Biotech, Inc. (Taipei City, TW). The FDA issued a Cleared decision on January 19, 2022 after a review of 467 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3920 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Franz Biotech, Inc. devices

FDA 510(k) Submission Details - K203072

510(k) Number K203072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2020
Decision Date January 19, 2022
Days to Decision 467 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
340d slower than avg
Panel avg: 127d · This submission: 467d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELL Device Classification - Class 2, Special Controls

Product Code ELL Teeth, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELL Teeth, Porcelain

All 29
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K203072.
Additive Manufacturing Zirconia Customized Restoration
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K162043 · Nobel Biocare AB · Nov 2016
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K153534 · Nobel Biocare AB · Jun 2016
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
K071182 · Nobel Biocare AB · Jul 2007
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
K060530 · Lifecore Biomedical, Inc. · May 2006
PROCERA BRIDGE ZIRCONIA
K041283 · Nobel Biocare AB · May 2004