Cleared Traditional

K020646 - REPLACE HA COATED IMPLANT

K020646 is the FDA 510(k) clearance for REPLACE HA COATED IMPLANT by Nobel Biocare Uas, Inc.. It is a Class 2 Dental device (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

Submission Details

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.

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 672
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K020646.
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · Straumann USA · Sep 2002
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · Vident · Sep 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584 · Nobel Biocare Uas, Inc. · Jun 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · Implant Innovations, Inc. · May 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · BioHorizons Implant Systems, Inc. · Mar 2002
ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
K020096 · Institut Straumann AG · Feb 2002