Cleared Traditional

K062936 - NOBELPERFECT CONICAL CONNECTION

K062936 is the FDA 510(k) clearance for NOBELPERFECT CONICAL CONNECTION by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K062936 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
82d
Days
Class 2
Risk

K062936 is an FDA 510(k) clearance for the NOBELPERFECT CONICAL CONNECTION. 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 December 19, 2006 after a review of 82 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 K062936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date December 19, 2006
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
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 K062936.
NANOTITE DENTAL IMPLANTS
K062432 · Implant Innovations, Inc. · Feb 2007
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
K063523 · Zimmer Dental, Inc. · Feb 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718 · Nobel Biocare AB · Jan 2007
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