Cleared Traditional

K053050 - PROCERA BRIDGE ALUMINA

K053050 is the FDA 510(k) clearance for PROCERA BRIDGE ALUMINA by Nobel Biocare AB. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K053050 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
117d
Days
Class 2
Risk

K053050 is an FDA 510(k) clearance for the PROCERA BRIDGE ALUMINA. 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 22, 2006 after a review of 117 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K053050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2005
Decision Date February 22, 2006
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
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
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K053050.
ZIMMER DENTAL ONE PIECE TAPERED ABUTMENT, MODELS TAC1, TACW1, TA5C1
K060880 · Zimmer Dental, Inc. · May 2006
PROVIDE TEMPORARY CYLINDER
K061177 · Implant Innovations, Inc. · May 2006
PREFORMANCE TEMPORARY CYLINDER
K060291 · Implant Innovations, Inc. · Feb 2006
PROCERA BRIDGE LAMINATE, MODEL 40-4002
K053068 · Nobel Biocare AB · Feb 2006
PROCERA BRIDGE ZIRCONIA
K053125 · Nobel Biocare AB · Feb 2006
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
K053099 · BioHorizons Implant Systems, Inc. · Feb 2006