FDA.reportPublic FDA data

ATOZ Expander Kit

Primary DI
08800197900341
Brand
ATOZ Expander Kit
Company
MK Meditech Inc.
Model
ATOZ Expander Kit
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*1eaATOZ Key: MK Key-L*1ea, MK Key-S*1eaATOZ Mini-Screw: MKS-1611*8eaATOZ Screwdriver MKD-S *1ea, MKD-L*1eaATOZ Tooth connecting arms: MK Wire arm-1240*4ea
Published
2023-10-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRetainer, Screw Expansion, Orthodontic
DZCWire, Orthodontic
NDPAccessories, Implant, Dental, Endosseous
OATImplant, Endosseous, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1
DZCWire, OrthodonticDental1
NDPAccessories, Implant, Dental, EndosseousDental1
OATImplant, Endosseous, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800197900341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800197900341088001979003418800197900341

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
695009476
Device count
1
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800197900020ATOZ Mini-ScrewMKS-1611 and MKS-16132022-01-22
08800197900624ATOZ Mini-ScrewMKS-1610 *10EA2025-11-03
08800197901034ATOZ Mini-ScrewMKS-1608 *10EA2025-11-03
08800197901621ATOZ KeyMK Key-T-S2025-11-03
08800197900396ATOZ Utility WireMK Wire arm-1260 * 4EA2024-12-27
08800197900389Guide ATOZMK-G-082024-12-26
08800197900549Model ATOZModel ATOZ-A-UNI-F082024-12-26
08800197900556ATOZ ScrewdriverMKD-S2024-12-23
08800197900563ATOZ ScrewdriverMKD-L2024-12-23
08800197900693ATOZ KeyMK Key-S2024-12-23
08800197900631ATOZ Mini-ScrewMKS-1610 *6EA2024-12-18
08800197900648ATOZ Mini-ScrewMKS-1611 *10EA2024-12-18
08800197900655ATOZ Mini-ScrewMKS-1611 *4EA2024-12-18
08800197900662ATOZ Mini-ScrewMKS-1613 *10EA2024-12-18
08800197900679ATOZ Mini-ScrewMKS-1613 *6EA2024-12-18
08800197900686ATOZ Mini-ScrewMKS-1615 *6EA2024-12-18
08800197900372ATOZ ExpanderA-UNI-F082024-05-16
08800197900198ATOZ Mini-ScrewMKS-16112024-01-12
08800197900358ATOZ ExpanderT-UNI-F122024-01-12
08800197900334ATOZ Mini-ScrewMKS-1611 * 8EA2023-10-13

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Primary DI, Brand, Company table
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08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
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08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
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