ATOZ Mini-Screw
MK Meditech Inc.
MK MEDITECH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3018070878 | 3018070878 | MK MEDITECH | 1 | N | 2026-01-01 | Room # 511, 54, Changeop-ro, Sujeong-gu Seongnam-si Gyeonggi KR 13449 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 288608 | 1868137007 | K210559 | ATOZ Mini-Screw | OAT | 2021-12-19 |
| 288608 | 1024835166 | ||||
| 288608 | 1353425319 | ||||
| 288608 | 1394790658 | ||||
| 288608 | 1417753232 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OAT | 1 | 2021-12-19 |
PMN#
GUDID#
ATOZ Mini-Screw - DESCRIPTIONThe ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied.INDICATION FOR USEThe ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatmentTrade NameATOZ Mini-ScrewConsist ofMKS-1613*6EA + MKS-1611*2EA
2022-01-22
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2025-11-03
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2025-11-03
ATOZ Key - DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside the mouth. There are two sizes available for the ATOZ key. INDICATION FOR USEThis is a product to expand the ATOZ expander.TRADE NAMEATOZ KeyMODEL NUMBERShorter key (MK Key-T-S)
2025-11-03
ATOZ Utility Wire - PRODUCT SUMMARYThis is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement.TRADE NAMEATOZ Utility WireMODEL NAMEMK Wire arm-1260INDICATION FOR USEThis can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan.PRODUCT MATERIAL316 Stainless SteelCONSIST OF: MK Wire arm-1260*4ea
2024-12-27
Guide ATOZ - DESCRIPTIONWhen installing the ATOZ Expander on the patient's palate, this is a semi-transparent plastic guide that helps ensure the correct orientation of the ATOZ Drill Bit or ATOZ screwdriver, facilitating the smooth placement of ATOZ Mini-ScrewsINDICATION FOR USEThe Guide ATOZ is used to assist in the process of installing the ATOZ Expander.TRADE NAMEGuide ATOZ MODEL NUMBERMK-G-08
2024-12-26
Model ATOZ - DESCRIPTIONThe plastic duplicate is a simplified form of the real ATOZ Expander. They are used to fabricate a surgical guide to hold the real ATOZ Expander in place on the palate during the anchoring screw placement. The Model ATOZ is used for making a surgical guide for ATOZ Expander. INDICATION FOR USEThe Model ATOZ is used for making a surgical guide for the ATOZ Expander.TRADE NAMEModel ATOZ MODEL NUMBERModel ATOZ-A-UNI-F08
2024-12-26
ATOZ Screwdriver - 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-SCOSIST OFMKD-S *1EA
2024-12-23
ATOZ Screwdriver - 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
2024-12-23
ATOZ Key - DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside the mouth. There are two sizes available for the ATOZ key. INDICATION FOR USEThis is a product to expand the ATOZ expander.TRADE NAMEATOZ KeyMODEL NUMBERShorter key (MK Key-S)
2024-12-23
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-12-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-12-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-12-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-12-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-12-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-12-18
ATOZ Expander - The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch.For the procedure, the ATOZ Expander is placed under the patient's palate, and the ATOZ Mini-Screw and the ATOZ Screwdriver, which are registered with the FDA separately from this product, are used to fix the ATOZ Expander. After that, use the ATOZ activation key to expand this product. The patient's palate is then forcibly opened by the force of the expander. The gap will naturally form bone over time and remain permanently expanded, and the ATOZ Expander and the ATOZ Mini-Screw are removed when the patient's palate is sufficiently wide.INDICATION FOR USEThe ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary archTrade Name: ATOZ ExpanderModel Number: A-UNI-F08
2024-05-16
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2024-01-12
ATOZ Expander - The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch.For the procedure, the ATOZ Expander is placed under the patient's palate, and the ATOZ Mini-Screw and the ATOZ Screwdriver, which are registered with the FDA separately from this product, are used to fix the ATOZ Expander. After that, use the ATOZ activation key to expand this product. The patient's palate is then forcibly opened by the force of the expander. The gap will naturally form bone over time and remain permanently expanded, and the ATOZ Expander and the ATOZ Mini-Screw are removed when the patient's palate is sufficiently wide.INDICATION FOR USEThe ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary archTrade Name: ATOZ ExpanderModel Number: T-UNI-F12
2024-01-12
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2023-10-13
ATOZ Expander Kit - 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
2023-10-13
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2023-07-19
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2023-07-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2023-07-18
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2022-03-04
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2022-03-04
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2022-03-04
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2022-03-04
ATOZ Mini-Screw - The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use. It is also disposable and not reused. The material of the ATOZ Mini-Screw is Titanium Alloy (ASTM F136), which is widely used in dental implants, and due to the nature of the temporary screw that is removed before bone union occurs, no surface treatment is applied
2022-03-04
ATOZ Expander Kit - 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*2ea, MKS-1613*8eaATOZ Screwdriver MKD-S *1ea, MKD-L*1eaATOZ Tooth connecting arms: MK Wire arm-1240*4ea
2022-01-22
ATOZ Expander Kit - ATOZ Expander Kit *10SET
2022-01-22
ATOZ-Tooth Connection Arms - PRODUCT SUMMARYThis is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement.TRADE NAMEATOZ Wire arm * 4EAMODEL NAMEMK Wire arm-1240INDICATION FOR USEThis can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan.PRODUCT MATERIAL316L Stainless SteelCONSIST OF: MK-Wire arm-1240*4ea
2022-01-22
MK Drill Bit - The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is used to mark the ATOZ Mini-Screw placement site or to form a small lead hole to facilitate mini-screw placement by reducing placement resistance.The MK Drill Bit is made of stainless steel (ASTM F899 420B).
2023-08-29
MK Drill Bit - MKDB-DG-08 * 10EA
2023-01-10
MK Drill Bit - The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is used to mark the ATOZ Mini-Screw placement site or to form a small lead hole to facilitate mini-screw placement by reducing placement resistance.The MK Drill Bit is made of stainless steel (ASTM F899 420B).
2022-06-09
MK Drill Bit - The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is used to mark the ATOZ Mini-Screw placement site or to form a small lead hole to facilitate mini-screw placement by reducing placement resistance.The MK Drill Bit is made of stainless steel (ASTM F899 420B).
2022-06-09
MK Drill Bit - The MK Drill Bit is an instrument that removes bone in combination with a medical handpiece for orthodontic treatment. It is used to mark the ATOZ Mini-Screw placement site or to form a small lead hole to facilitate mini-screw placement by reducing placement resistance.The MK Drill Bit is made of stainless steel (ASTM F899 420B).
2022-06-09
ATOZ Expander - The ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary arch.For the procedure, the ATOZ Expander is placed under the patient's palate, and the ATOZ Mini-Screw and the ATOZ Screwdriver, which are registered with the FDA separately from this product, are used to fix the ATOZ Expander. After that, use the ATOZ activation key to expand this product. The patient's palate is then forcibly opened by the force of the expander. The gap will naturally form bone over time and remain permanently expanded, and the ATOZ Expander and the ATOZ Mini-Screw are removed when the patient's palate is sufficiently wide.INDICATION FOR USEThe ATOZ Expander is used to stretch and split the mid-palatal suture and subsequently increase the width of the maxillary archTrade Name: ATOZ ExpanderModel Number: MKE-08-F
2022-01-22
ATOZ Screwdriver - 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-S and MKD-LCOSIST OFMKD-S *1EA + MKD-L*1EA
2022-01-22
ATOZ Key - DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Expander to generate the expansion force inside the mouth. There are two sizes available for the ATOZ key. INDICATION FOR USEThis is a product to expand the ATOZ expander.TRADE NAMEATOZ KeyMODEL NUMBERLonger key (MK Key-L), Shorter key (MK Key-S)
2022-01-22