Cleared Traditional

K032562 - PROCEARA COPINGS AND PONTIC

K032562 is an FDA 510(k) clearance for PROCEARA COPINGS AND PONTIC, 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 170-day FDA review.

K032562 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
170d
Days
Class 2
Risk

K032562 is an FDA 510(k) clearance for the PROCEARA COPINGS AND PONTIC. 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 February 6, 2004 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Nobel Biocare AB devices

FDA 510(k) Submission Details - K032562

510(k) Number K032562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2003
Decision Date February 06, 2004
Days to Decision 170 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
43d slower than avg
Panel avg: 127d · This submission: 170d
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 K032562.
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
ARGI-SATIN OR OPTI0-STAR
K965216 · Argen Precious Metals, Inc. · Feb 1997
MATCHMAKER/PROPAQUE PORCELAIN
K960770 · Davis Schottlander & Davis, Ltd. · Nov 1996
IN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013
K960480 · Vident · Mar 1996