Cleared Traditional

K020646 - REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

K020646 is an FDA 510(k) clearance for REPLACE HA COATED IMPLANT, manufactured by Nobel Biocare Uas, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020646 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
90d
Days
Class 2
Risk

K020646 is an FDA 510(k) clearance for the REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 5.... 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 May 29, 2002 after a review of 90 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 Uas, Inc. devices

FDA 510(k) Submission Details - K020646

510(k) Number K020646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2002
Decision Date May 29, 2002
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 1243
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K020646.
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · Vident · Sep 2002
XIVE DENTAL IMPLANT SYSTEM
K021318 · Friadent GmbH · Jul 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584 · Nobel Biocare Uas, Inc. · Jun 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · Implant Innovations, Inc. · May 2002
ACE HA SCREW DENTAL IMPLANT SYSTEM
K021244 · Ace Surgical Supply Co., Inc. · May 2002
IMMEDIATE STABILIZING DEVICE (ISD)
K011524 · "O" Co., Inc. · Apr 2002