Cleared Traditional

K061529 - PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IM...

K061529 is the FDA 510(k) clearance for PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IM... by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K061529 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
82d
Days
Class 2
Risk

K061529 is an FDA 510(k) clearance for the PROCERA ZIRCONIA ABUTMENT FOR CAMLOG IMPLANT SYSTEM. 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 August 23, 2006 after a review of 82 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

Submission Details

510(k) Number K061529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date August 23, 2006
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 463
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