Cleared Traditional

K031936 - OSTEOMED ORTHODONTIC SCREW SYSTEM

K031936 is an FDA 510(k) clearance for OSTEOMED ORTHODONTIC SCREW SYSTEM, manufactured by Osteomed LP. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K031936

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
Combination Product No
PCCP Authorized No
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.

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 1268
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
IMMEDIATE STABILIZING IMPLANT (ISI)
K033392 · "O" Co., Inc. · Dec 2003
RENOVA INTERNAL HEX IMPLANT SYSTEM
K032774 · Lifecore Biomedical, Inc. · Nov 2003