Cleared Traditional

K051751 - EQUA-PULL SAFETY RELEASE MODULE

K051751 is an FDA 510(k) clearance for EQUA-PULL SAFETY RELEASE MODULE, manufactured by Ortho Technology. The device is a Class 2 Dental device with product code DZB cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K051751 · Ortho Technology · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
23d
Days
Class 2
Risk

K051751 is an FDA 510(k) clearance for the EQUA-PULL SAFETY RELEASE MODULE. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Ortho Technology (Tampa, US). The FDA issued a Cleared decision on July 22, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - 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.

FDA 510(k) Submission Details - K051751

510(k) Number K051751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date July 22, 2005
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZB Device Classification - Class 2, Special Controls

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
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 - DZB Headgear, Extraoral, Orthodontic

All 30
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K051751.
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
K111169 · Kwang Myung Daicom, Inc. · Oct 2011
KJ MASK
K103019 · Kj Meditech Co., Ltd. · Jun 2011
NITOM LOCKING FACEBOW
K052553 · Russell Samuels Orthodontic Design · Dec 2005
KELES FACEMASK
K041718 · Great Lakes Orthodontics, Ltd. · Oct 2004
MORALES PROTRACTION FACEMASK
K032392 · Ortosim, S.A. DE C.V. · Oct 2003
MULTI ADJUSTABLE FACE MASK
K000358 · Ortho Technology · Jun 2000
K051751 · EQUA-PULL SAFETY RELEASE MODULE
Download PDF Ortho Technology