FDA.reportPublic FDA data

ATOZ Screwdriver

Primary DI
08800197900563
Brand
ATOZ Screwdriver
Company
MK Meditech Inc.
Model
MKD-L
Device description
PRODUCT SUMMARYThis is used for insertion and removal of the ATOZ Mini-screw. The driver is designed just for MK Mini-screw (MKS-1611, MKS-1613), so it does not fit other types of mini-screws.INDICATION FOR USEThis is used for insertion and removal of the ATOZ Mini-screwTRADE NAME ATOZ ScrewdriverMODEL NAME MKD-LCOSIST OFMKD-L*1EA
Published
2024-12-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800197900563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800197900563088001979005638800197900563

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
Premarket exempt
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
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
08800197900341ATOZ Expander KitATOZ Expander Kit2023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14