Cleared Traditional

K050406 - NOBELSPEEDY IMPLANTS

K050406 is the FDA 510(k) clearance for NOBELSPEEDY IMPLANTS by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K050406 · Nobel Biocare AB · Dental device
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Jun 2005
Decision
111d
Days
Class 2
Risk

K050406 is an FDA 510(k) clearance for the NOBELSPEEDY 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 June 8, 2005 after a review of 111 days - within the typical 510(k) review window.

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: 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 K050406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2005
Decision Date June 08, 2005
Days to Decision 111 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
16d faster than avg
Panel avg: 127d · This submission: 111d
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 K050406.
BIOHORIZONS SINGLE-STAGE IMPLANT
K053152 · BioHorizons Implant Systems, Inc. · Dec 2005
MAXIMUS 3.0 AND OS IMPLANTS
K052419 · BioHorizons Implant Systems, Inc. · Sep 2005
3I OSSEOTITE DENTAL IMPLANTS
K051461 · Implant Innovations, Inc. · Sep 2005
PREVAIL DENTAL IMPLANTS
K051189 · Implant Innovations, Inc. · Jun 2005
TIUNITE IMPLANTS
K050705 · Nobel Biocare AB · May 2005
THE GUIDED SURGERY CONCEPT
K050393 · Nobel Biocare AB · May 2005