Cleared Traditional

K071182 - PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013

K071182 is an FDA 510(k) clearance for PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, 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 72-day FDA review.

K071182 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
72d
Days
Class 2
Risk

K071182 is an FDA 510(k) clearance for the PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013. 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 July 11, 2007 after a review of 72 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 - K071182

510(k) Number K071182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2007
Decision Date July 11, 2007
Days to Decision 72 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
55d faster than avg
Panel avg: 127d · This submission: 72d
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 K071182.
Franz Zirconia Dental Crown
K203072 · Franz Biotech, Inc. · Jan 2022
NobelProcera HT ML FCZ Bridge
K162043 · Nobel Biocare AB · Nov 2016
NobelProcera HT ML Full Contour Zirconia Crown
K153534 · Nobel Biocare AB · Jun 2016
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
PROCEARA COPINGS AND PONTIC
K032562 · Nobel Biocare AB · Feb 2004