Cleared Traditional

K022424 - REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162

K022424 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 65-day FDA review.

K022424 · Nobel Biocare Uas, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
65d
Days
Class 2
Risk

K022424 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 September 27, 2002 after a review of 65 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 Uas, Inc. devices

FDA 510(k) Submission Details - K022424

510(k) Number K022424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2002
Decision Date September 27, 2002
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 K022424.
IMTEC SENDAX MDI ORTHO6 AND ORTHO8
K023067 · Imtec Corp. · Dec 2002
VARIOUS BRANEMARK SYSTEM IMPLANTS-IMMEDIATE FUNCTION INDICATION
K022562 · Nobel Biocare AB · Oct 2002
OCO DENTAL IMPLANT (5.0MM DIAMETER)
K023336 · "O" Co., Inc. · Oct 2002
REPLACE TIUNITE ENDOSSEOUS IMPLANT
K023113 · Nobel Biocare Uas, Inc. · Sep 2002
3I DENTAL IMPLANT ACCESSORIES
K022113 · Implant Innovations, Inc. · Sep 2002
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · Straumann USA · Sep 2002