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SPEED Opening Instrument

FDA UDI

Class I (US FDA UDI)

by Hespeler Orthodontics Limited

Identity

Trade Name
SPEED Opening Instrument FDA UDI
Generic Name
Self-ligating orthodontic bracket open/close tool FDA UDI
Model / Reference
07540295000444 FDA UDI

Identifiers

Primary DI / UDI-DI
07540295000444 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Self-ligating orthodontic bracket open/close tool FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Category: Self-ligating orthodontic bracket open/close tool

SPEED Opening Instrument by Hespeler Orthodontics Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-ligating orthodontic bracket open/close tool.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hespeler Orthodontics Limited

Sources (1)

  • FDA UDI 5f2103da-d1a9-414a-8f5f-78d25165e1d5 32 fields · synced May 30, 2026