Kit Advanced Metal Brackets Roth 0.022 01 Set + Arches + Elastics

FDA UDIEUDAMED

Class I (US FDA UDI)

by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

Identity

Trade Name: KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICS FDA UDI
Generic Name: Orthodontic bracket, metal FDA UDI
Device Name: 1 SET OF METAL BRACKETS 1 PAIR OF ARCHWIRES 1 BAG ELASTIC STICK LIGATURE - ASSORTMENT OF COLORS FDA UDI
Model / Reference: 10.10.2801 FDA UDI
Description: 1 SET OF METAL BRACKETS 1 PAIR OF ARCHWIRES 1 BAG ELASTIC STICK LIGATURE - ASSORTMENT OF COLORS FDA UDI

Identifiers

Primary DI / UDI-DI: 07908470704912 FDA UDI
FDA Product Code: EJF FDA UDI
DZC FDA UDI
ECI FDA UDI
GMDN Term: Orthodontic bracket, metal 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthodontic archwire Orthodontic bracket, metal Orthodontic inter-arch elastic band

Kit Advanced Metal Brackets Roth 0.022 01 Set + Arches + Elastics by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class I…

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

Sources (2)

FDA UDI 021dfeea-c0f1-4607-91ac-477d05e95ed7 33 fields · synced Jun 20, 2026
EUDAMED 1 fields · synced Jun 1, 2026