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dentaform®

FDA UDI

Class I (US FDA UDI)

by Dentaurum

Identity

Trade Name
dentaform® FDA UDI
Generic Name
Orthodontic metal band FDA UDI
Device Name
dentaform® Band, Tooth 16, Size 36 FDA UDI
Model / Reference
882-036-00 FDA UDI
Description
dentaform® Band, Tooth 16, Size 36 FDA UDI

Identifiers

Primary DI / UDI-DI
J011882036000 FDA UDI
FDA Product Code
ECM FDA UDI
GMDN Term
Orthodontic metal band 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Orthodontic metal band

At DENTAURUM GmbH & Co.KG, we offer a comprehensive range of orthodontic solutions, including the dentaform Band. This single-patient device is designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment. With its unique metal band design, it's an ideal solution for dental professionals seeking to treat their patients with precision and accuracy.

Similar devices

Also classified as Orthodontic metal band.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentaurum

Sources (1)

  • FDA UDI 2b4b1126-72c8-49d8-a8f2-cecb447fb0ef 35 fields · synced Jul 2, 2026