MK Meditech Inc.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Implant, Endosseous, Orthodontic (OAT) (6) Retainer, Screw Expansion, Orthodontic (DYJ) (4) Accessories, Implant, Dental, Endosseous (NDP) (3) Wire, Orthodontic (DZC) (3)

Premarket Exempt

No Yes

Clear

ATOZ Mini-Screw - 08800197900020 Catalog Number :

Device Description : DESCRIPTIONThe ATOZ Mini-Screw is intended for use as a temporary anchor for ort

Device Class : 2

Duns Number: 695009476

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 1

ATOZ Expander - 08800197900037 Catalog Number :

Device Description : The ATOZ Expander is used to stretch and split the mid-palatal suture and subseq

Device Class : 1

Duns Number: 695009476

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

ATOZ-Tooth Connection Arms - 08800197900044 Catalog Number :

Device Description : PRODUCT SUMMARYThis is a bendable stainless steel wire which can be connected to

Device Class : 1

Duns Number: 695009476

Premarket Exempt : Yes

Product Code : DZC

Prescription Use : Yes

Device Count : 1

ATOZ Screwdriver - 08800197900051 Catalog Number :

Device Description : PRODUCT SUMMARYThis is used for insertion and removal of the ATOZ Mini-screw. Th

Device Class : 1

Duns Number: 695009476

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ATOZ Expander Kit - 08800197900068 Catalog Number :

Device Description : The ATOZ Expander Kit is a procedure kit used for orthodontic treatment and cons

Device Class : 1

Duns Number: 695009476

Premarket Exempt : No

Product Code : DYJ, OAT, DZC, NDP

Prescription Use : Yes

Device Count : 1

ATOZ Expander Kit - 08800197900075 Catalog Number :

Device Description : ATOZ Expander Kit *10SET

Device Class : 1

Duns Number: 695009476

Premarket Exempt : No

Product Code : DYJ, OAT, DZC, NDP

Prescription Use : Yes

Device Count : 1

ATOZ Key - 08800197900082 Catalog Number :

Device Description : DESCRIPTIONThis is a hexagonal wrench to rotate the hexagonal nut of the ATOZ Ex

Device Class : 1

Duns Number: 695009476

Premarket Exempt : Yes

Product Code : DYJ

Prescription Use : Yes

Device Count : 1

ATOZ Mini-Screw - 08800197900099 Catalog Number :

Device Description : The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic tr

Device Class : 2

Duns Number: 695009476

Premarket Exempt : No

Product Code : OAT

Prescription Use : Yes

Device Count : 1

ATOZ Mini-Screw - 08800197900105 Catalog Number :

Device Description : The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic tr

Device Class : 2

Duns Number: 695009476

Premarket Exempt : No

Product Code : OAT

Prescription Use : No

Device Count : 1

ATOZ Mini-Screw - 08800197900112 Catalog Number :

Device Description : The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic tr

Device Class : 2

Duns Number: 695009476

Premarket Exempt : No

Product Code : OAT

Prescription Use : No

Device Count : 1

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