Cleared Traditional

K041283 - PROCERA BRIDGE ZIRCONIA

K041283 is an FDA 510(k) clearance for PROCERA BRIDGE ZIRCONIA, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code ELL cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K041283 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
15d
Days
Class 2
Risk

K041283 is an FDA 510(k) clearance for the PROCERA BRIDGE ZIRCONIA. Classified as Teeth, Porcelain (product code ELL), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nobel Biocare AB devices

FDA 510(k) Submission Details - K041283

510(k) Number K041283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2004
Decision Date May 28, 2004
Days to Decision 15 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
112d faster than avg
Panel avg: 127d · This submission: 15d
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 30
Devices cleared under the same product code (ELL) and FDA review panel - the closest regulatory comparables to K041283.
NobelProcera HT ML Full Contour Zirconia Crown
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
PROCEARA COPINGS AND PONTIC
K032562 · Nobel Biocare AB · Feb 2004
ARGI-SATIN OR OPTI0-STAR
K965216 · Argen Precious Metals, Inc. · Feb 1997
MATCHMAKER/PROPAQUE PORCELAIN
K960770 · Davis Schottlander & Davis, Ltd. · Nov 1996