Cleared Traditional

K040891 - KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES)

K040891 is the FDA 510(k) clearance for KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES) by KLS-Martin L.P.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K040891 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
53d
Days
Class 2
Risk

K040891 is an FDA 510(k) clearance for the KLS MARTIN ORTHO ANCHORAGE SYSTEM (PLATES). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 53 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 KLS-Martin L.P. devices

Submission Details

510(k) Number K040891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2004
Decision Date May 28, 2004
Days to Decision 53 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
74d faster than avg
Panel avg: 127d · This submission: 53d
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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K040891.
MAXIMUS OS (OVERDENTURE SYSTEM)
K041938 · BioHorizons Implant Systems, Inc. · Jul 2004
STRAUMANN DENTAL IMPLANT SYSTEM
K033984 · Institut Straumann AG · Jun 2004
MODIFICATION TO OSSEOTITE NT CERTAIN IMPLANTS
K041402 · Implant Innovations, Inc. · Jun 2004
LORENZ SELF-DRILLING IMF SCREW
K040983 · Walter Lorenz Surgical, Inc. · May 2004
DUAL TOP ANCHOR SYSTEM SCREWS
K033767 · Jeil Medical Corporation · Feb 2004
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
K030685 · Nobel Biocare AB · Feb 2004