Cleared Traditional

K033724 - NOBEL BIOCARE CENTRIC POST

K033724 is the FDA 510(k) clearance for NOBEL BIOCARE CENTRIC POST by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K033724 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
89d
Days
Class 2
Risk

K033724 is an FDA 510(k) clearance for the NOBEL BIOCARE CENTRIC POST, MODELS 31234, 31235 AND 31236. 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 Uas, Inc. (Yorba Linda,, US). The FDA issued a Cleared decision on February 23, 2004 after a review of 89 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 Uas, Inc. devices

Submission Details

510(k) Number K033724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date February 23, 2004
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
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 480
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K033724.
NOBEL BIOCARE PERMANENT CENTRIC POST, MODELS 31234, 31235, 31236
K040573 · Nobel Biocare Uas, Inc. · Apr 2004
3I PATIENT-SPECIFIC OVERDENTURE BAR
K034035 · Implant Innovations, Inc. · Mar 2004
ELLIPTIC MATRIX
K040539 · Institut Straumann AG · Mar 2004
ITI SYNOCTA MESO ABUTMENTS
K033243 · Straumann USA · Oct 2003
DENTAL IMPLANT COPING (PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM)
K032498 · Straumann USA · Aug 2003
ESTHETIC ZIRCONIA ABUTMENT
K031719 · Nobel Biocare AB · Jul 2003