Device Description : DESCRIPTIONThe ATOZ Mini-Screw is intended for use as a temporary anchor for ort 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*8EA + MKS-1611*2EA
Device Class : 2
Duns Number: 695009476
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ATOZ Expander is used to stretch and split the mid-palatal suture and subseq 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
Device Class : 1
Duns Number: 695009476
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : PRODUCT SUMMARYThis is a bendable stainless steel wire which can be connected to 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 armMODEL 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
Device Class : 1
Duns Number: 695009476
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : PRODUCT SUMMARYThis is used for insertion and removal of the ATOZ Mini-screw. Th 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
Device Class : 1
Duns Number: 695009476
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and cons 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
Device Class : 1
Duns Number: 695009476
Premarket Exempt : No
Prescription Use : Yes
Device Description : ATOZ Expander Kit *10SET
Device Class : 1
Duns Number: 695009476
Premarket Exempt : No
Prescription Use : Yes
Device Description : DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Ex 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)
Device Class : 1
Duns Number: 695009476
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic tr 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
Device Class : 2
Duns Number: 695009476
Premarket Exempt : No
Prescription Use : Yes
Device Description : The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic tr 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
Device Class : 2
Duns Number: 695009476
Premarket Exempt : No
Prescription Use : No
Device Description : The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic tr 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
Device Class : 2
Duns Number: 695009476
Premarket Exempt : No
Prescription Use : No