Orthometric Burs

FDA UDI

Class I (US FDA UDI)

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

Identity

Trade Name: ORTHOMETRIC BURS FDA UDI
Generic Name: Carbide dental bur, reusable FDA UDI
Device Name: ORTHOMETRIC BURS FOR ORTHODONTIC ADHESIVE REMOVAL- LOW ROTATION FDA UDI
Model / Reference: 75.80.1004 FDA UDI
Description: ORTHOMETRIC BURS FOR ORTHODONTIC ADHESIVE REMOVAL- LOW ROTATION FDA UDI

Identifiers

Catalog Number: 75.80.1004 FDA UDI
Primary DI / UDI-DI: 07898488906968 FDA UDI
FDA Product Code: EJL FDA UDI
GMDN Term: Carbide dental bur, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3240 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

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

FDA UDI

Category: Carbide dental bur, reusable

Orthometric Burs by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class I — FDA UDI — listed in FDA GUDID

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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

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Manufacturer

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

Sources (1)

FDA UDI e94be5c7-202d-44bd-baf1-343019047085 34 fields · synced Jun 6, 2026