Cleared Traditional

K031345 - NOBEL DIRECT

K031345 is the FDA 510(k) clearance for NOBEL DIRECT by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K031345 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
86d
Days
Class 2
Risk

K031345 is an FDA 510(k) clearance for the NOBEL DIRECT, MODELS 30937, 30938. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare Uas, Inc. (Yorba Linda,, US). The FDA issued a Cleared decision on July 24, 2003 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 K031345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2003
Decision Date July 24, 2003
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031345.
OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS
K031632 · Implant Innovations, Inc. · Sep 2003
3I DENTAL IMPLANTS
K030614 · Implant Innovations, Inc. · Sep 2003
OSSEOTITE NT CERTAIN IMPLANTS
K031475 · Implant Innovations, Inc. · Jul 2003
ITI DENTAL IMPLANT SYSTEM
K031055 · Straumann USA · Jul 2003
ITI DENTAL IMPLANT SYSTEM
K030007 · Straumann USA · Mar 2003
MODIFICATION TO THE MAESTRO SYSTEM
K030463 · BioHorizons Implant Systems, Inc. · Feb 2003