Cleared Traditional

K000358 - MULTI ADJUSTABLE FACE MASK

K000358 is an FDA 510(k) clearance for MULTI ADJUSTABLE FACE MASK, 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 126-day FDA review.

K000358 · Ortho Technology · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
126d
Days
Class 2
Risk

K000358 is an FDA 510(k) clearance for the MULTI ADJUSTABLE FACE MASK. 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 June 9, 2000 after a review of 126 days - within the typical 510(k) review window.

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: 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 Ortho Technology devices

FDA 510(k) Submission Details - K000358

510(k) Number K000358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2000
Decision Date June 09, 2000
Days to Decision 126 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 127d · This submission: 126d
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 15
Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K000358.
Orthodontic Facemask
K202855 · Ita.O Italian Orthodontic System S.R.L. · Jun 2021
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
T-GEAR, MODEL TG/400-700
K993224 · Dontech Products B.V. · Feb 2000
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM
K982088 · Ortho Kinetics Corp. · Sep 1998
CLASS III REVERSE PULL FACEMASK
K980436 · Ortho Kinetics Corp. · Apr 1998
NITOM LOCKING FACEBOW
K980245 · Ortho Kinetics Corp. · Apr 1998