ATOZ Expander Kit

Basic Information

• Brand Name: ATOZ Expander Kit
• Primary DI: 08800197900341
• Version / Model: ATOZ Expander Kit
• Company Name: MK Meditech Inc.
• Labeler DUNS: 695009476
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-13
• Public Version: 2
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: b5cd9ca0-ba2e-4d6c-9641-0bbb2c4e1e96

Device Description

The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and consists of an expander, screws, drivers, wires, and accessories. ATOZ Expander:MKE-08-F*1ea ATOZ Key: MK Key-L*1ea, MK Key-S*1ea ATOZ Mini-Screw: MKS-1611*8ea ATOZ Screwdriver MKD-S *1ea, MKD-L*1ea ATOZ Tooth connecting arms: MK Wire arm-1240*4ea

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	872.5410	1
OAT	Implant, Endosseous, Orthodontic	Dental	872.3640	2
DZC	Wire, Orthodontic	Dental	872.5410	1
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active
41397	Orthodontic archwire	A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active
46536	Orthodontic anchoring screw	A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.	Yes	Active
64768	Orthodontic palate expander screw key	A hand-held device designed to manually adjust an orthodontic palate expander (not included), by rotating the expander’s screw, to help create space for correct upper teeth alignment. It is comprised of a handle with an expander-engaging pin at the distal end which is inserted into the screw and rotated to adjust the width of the expander. This is a reusable device intended for single patient use.	No	Active
64769	Orthodontic palate expander/teeth aligner, bonded	An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism, positioned in the palate cavity with wires extending laterally, ending in bonded teeth-engaging bands. It is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to effect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800197900341	GS1