Cleared Traditional

K062566 - NOBELREPLACE TAPERED CONICAL CONNECTION

K062566 is an FDA 510(k) clearance for NOBELREPLACE TAPERED CONICAL CONNECTION, manufactured by Nobel Biocare USA, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K062566 · Nobel Biocare USA, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
97d
Days
Class 2
Risk

K062566 is an FDA 510(k) clearance for the NOBELREPLACE TAPERED CONICAL CONNECTION. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare USA, LLC (Yorba Linda,, US). The FDA issued a Cleared decision on December 6, 2006 after a review of 97 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 USA, LLC devices

FDA 510(k) Submission Details - K062566

510(k) Number K062566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date December 06, 2006
Days to Decision 97 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 840
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K062566.
SPI ELEMENT PLATFORM O 4.0 MM
K070007 · Thommen Medical AG · Jan 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718 · Nobel Biocare AB · Jan 2007
NOBELPERFECT CONICAL CONNECTION
K062936 · Nobel Biocare AB · Dec 2006
US SYSTEM
K062030 · Osstem Implant Co., Ltd. · Nov 2006
SS SYSTEM
K062051 · Osstem Implant Co., Ltd. · Nov 2006
P.0004 IMPLANTS
K062129 · Institut Straumann AG · Oct 2006