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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 128d · 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 1450
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K021322.
ENDOSSEOUS IMPLANT
K021355 · Branemark Integration AB · Aug 2002
3A DENTAL IMPLANT SYSTEM
K011879 · Osseco Biosource, Ltd. · Aug 2002
SCREWLINE
K022425 · Altatec Biotechnologies N.A., Inc. · Aug 2002
SPI ONETIME DENTAL IMPLANT
K022038 · Paxmed International · Jul 2002
XIVE DENTAL IMPLANT SYSTEM
K021318 · Friadent GmbH · Jul 2002
ERA IMPLANT
K021045 · Sterngold · Jun 2002
K021322 · ENDOSSOUS IMPLANTS
Download PDF FDA Summary Intra-Lock Internatio…