Cleared Traditional

K021355 - ENDOSSEOUS IMPLANT

K021355 is an FDA 510(k) clearance for ENDOSSEOUS IMPLANT, manufactured by Branemark Integration AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K021355 · Branemark Integration AB · Dental device
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Aug 2002
Decision
123d
Days
Class 2
Risk

K021355 is an FDA 510(k) clearance for the ENDOSSEOUS IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Branemark Integration AB (Gotborg, SE). The FDA issued a Cleared decision on August 30, 2002 after a review of 123 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 Branemark Integration AB devices

FDA 510(k) Submission Details - K021355

510(k) Number K021355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2002
Decision Date August 30, 2002
Days to Decision 123 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 127d · This submission: 123d
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 934
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K021355.
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