Cleared Traditional

K031936 - OSTEOMED ORTHODONTIC SCREW SYSTEM

K031936 is the FDA 510(k) clearance for OSTEOMED ORTHODONTIC SCREW SYSTEM by Osteomed LP. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K031936 · Osteomed LP · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
198d
Days
Class 2
Risk

K031936 is an FDA 510(k) clearance for the OSTEOMED ORTHODONTIC SCREW SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on January 7, 2004 after a review of 198 days - an extended review 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: 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 Osteomed LP devices

Submission Details

510(k) Number K031936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2003
Decision Date January 07, 2004
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
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 673
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K031936.
TEETH IN AN HOUR - ARK IMPLANT CONCEPT
K030685 · Nobel Biocare AB · Feb 2004
3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
K032263 · Implant Innovations, Inc. · Jan 2004
KLS-MARTIN ORTHO ANCHORAGE SYSTEM
K033483 · KLS-Martin L.P. · Jan 2004
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K033922 · Institut Straumann AG · Jan 2004
RENOVA INTERNAL HEX IMPLANT SYSTEM
K032774 · Lifecore Biomedical, Inc. · Nov 2003
3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
K033430 · Implant Innovations, Inc. · Nov 2003