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Excalibur

FDA UDI

Class I (US FDA UDI)

by GC Orthodontics America Inc.

Identity

Trade Name
Excalibur FDA UDI
Generic Name
Dental material application tool, reusable FDA UDI
Device Name
TN 3 Instrument FDA UDI
Model / Reference
55-0FU2-0000 FDA UDI
Description
TN 3 Instrument FDA UDI

Identifiers

Catalog Number
55-0FU2-0000 FDA UDI
Primary DI / UDI-DI
D788550FU200001 FDA UDI
FDA Product Code
DZN FDA UDI
GMDN Term
Dental material application tool, reusable 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental material application tool, reusable

Excalibur by GC Orthodontics America Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental material application tool, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GC Orthodontics America Inc.

Sources (1)

  • FDA UDI 700ebe22-6e5d-447d-80b5-3d12aaa83cff 35 fields · synced May 31, 2026