Cleared Traditional

K053602 - PROCERA SOFTWARE, MODEL 33145

K053602 is an FDA 510(k) clearance for PROCERA SOFTWARE, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K053602 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
49d
Days
Class 2
Risk

K053602 is an FDA 510(k) clearance for the PROCERA SOFTWARE, MODEL 33145. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on February 10, 2006 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 - K053602

510(k) Number K053602 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2005
Decision Date February 10, 2006
Days to Decision 49 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
78d faster than avg
Panel avg: 127d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 653
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K053602.
PROCERA BRIDGE ZIRCONIA
K053125 · Nobel Biocare AB · Feb 2006
CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES
K051636 · Altatec GmbH · Feb 2006
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
K053099 · BioHorizons Implant Systems, Inc. · Feb 2006
PREFORMANCE POSTS
K053170 · Implant Innovations, Inc. · Feb 2006
PROCERA IMPLANT BRIDGE ZIRCONIA
K053091 · Nobel Biocare AB · Jan 2006
STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026
K053643 · Lifecore Biomedical, Inc. · Jan 2006