Cleared Traditional

K050705 - TIUNITE IMPLANTS

K050705 is the FDA 510(k) clearance for TIUNITE IMPLANTS by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K050705 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
62d
Days
Class 2
Risk

K050705 is an FDA 510(k) clearance for the TIUNITE IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on May 19, 2005 after a review of 62 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 AB devices

Submission Details

510(k) Number K050705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2005
Decision Date May 19, 2005
Days to Decision 62 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
65d faster than avg
Panel avg: 127d · This submission: 62d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K050705.
3I OSSEOTITE DENTAL IMPLANTS
K051461 · Implant Innovations, Inc. · Sep 2005
NOBELSPEEDY IMPLANTS
K050406 · Nobel Biocare AB · Jun 2005
PREVAIL DENTAL IMPLANTS
K051189 · Implant Innovations, Inc. · Jun 2005
THE GUIDED SURGERY CONCEPT
K050393 · Nobel Biocare AB · May 2005
GROOVY IMPLANTS
K050258 · Nobel Biocare AB · Apr 2005
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · BioHorizons Implant Systems, Inc. · Sep 2004