Model ATOZ

FDA UDI

Class I (US FDA UDI)

by M.K. Meditech Co. , Ltd.

Identity

Trade Name: Model ATOZ FDA UDI
Generic Name: Orthodontic retainer support kit FDA UDI
Device Name: DESCRIPTION The 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 USE The Model ATOZ is used for making a surgical guide for the ATOZ Expander. TRADE NAME Model ATOZ MODEL NUMBER Model ATOZ-A-UNI-F08 FDA UDI
Model / Reference: Model ATOZ-A-UNI-F08 FDA UDI
Description: DESCRIPTION The 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 USE The Model ATOZ is used for making a surgical guide for the ATOZ Expander. TRADE NAME Model ATOZ MODEL NUMBER Model ATOZ-A-UNI-F08 FDA UDI

Identifiers

Primary DI / UDI-DI: 08800197900549 FDA UDI
FDA Product Code: DYJ FDA UDI
GMDN Term: Orthodontic retainer support kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5410 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthodontic retainer support kit

Model ATOZ by M.K. Meditech Co. , Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic retainer support kit.

Chewies — STRAIGHT SMILE LLC · Class I
SureSmile® — Dentsply Sirona Orthodontics Inc. · Class I
Guide ATOZ — M.K. Meditech Co. , Ltd. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: M.K. Meditech Co. , Ltd.

Sources (1)

FDA UDI 96a6a1c4-8d7d-42ed-9750-8237d2f1c6b8 33 fields · synced Jun 6, 2026