FDA.reportPublic FDA data

ATOZ Expander Kit

Primary DI
08800197900075
Brand
ATOZ Expander Kit
Company
MK Meditech Inc.
Model
ATOZ Expander Kit*10SET
Device description
ATOZ Expander Kit *10SET
Published
2022-01-22
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
08800197900075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800197900075088001979000758800197900075

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic palate expander screw keyA 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.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03