Cleared Abbreviated

K021322 - ENDOSSOUS IMPLANTS

K021322 is an FDA 510(k) clearance for ENDOSSOUS IMPLANTS, manufactured by Intra-Lock International. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 90-day FDA review.

K021322 · Intra-Lock International · Dental device
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Jul 2002
Decision
90d
Days
Class 2
Risk

K021322 is an FDA 510(k) clearance for the ENDOSSOUS IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Intra-Lock International (Boca Raton, US). The FDA issued a Cleared decision on July 24, 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Intra-Lock International devices

FDA 510(k) Submission Details - K021322

510(k) Number K021322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2002
Decision Date July 24, 2002
Days to Decision 90 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Standards-based clearance path.

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 866
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K021322.
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
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
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
K020646 · Nobel Biocare Uas, Inc. · May 2002