Cleared Traditional

K031207 - SAFETY RELEASE ARCH BAR KIT

K031207 is an FDA 510(k) clearance for SAFETY RELEASE ARCH BAR KIT, manufactured by Casey Surgical, LLC. The device is a Class 2 Dental device with product code DYX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K031207 · Casey Surgical, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
90d
Days
Class 2
Risk

K031207 is an FDA 510(k) clearance for the SAFETY RELEASE ARCH BAR KIT. Classified as Lock, Wire, And Ligature, Intraoral (product code DYX), Class II - Special Controls.

Submitted by Casey Surgical, LLC (Lee'S Summit, US). The FDA issued a Cleared decision on July 15, 2003 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 872.4600 - 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 Casey Surgical, LLC devices

FDA 510(k) Submission Details - K031207

510(k) Number K031207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2003
Decision Date July 15, 2003
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYX Device Classification - Class 2, Special Controls

Product Code DYX Lock, Wire, And Ligature, Intraoral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4600
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 - DYX Lock, Wire, And Ligature, Intraoral

Devices cleared under the same product code (DYX) and FDA review panel - the closest regulatory comparables to K031207.
ERCH ARCH BAR, MODEL 38-690-00
K061271 · KLS-Martin L.P. · Jun 2006
LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
K990212 · Doctor'S Research Group, Inc. · Sep 1999
SYNTHES QUICK LOCK IMF SYSTEM
K991004 · Synthes (Usa) · Jun 1999
IMPLANTABLE PULSE GENERATORS
K925106 · Medtronic Vascular · Oct 1993
RELIANCE SHORT STICK TIE
K925712 · Reliance Orthodontic Products, Inc. · Jan 1993