Spatula

FDA UDI

Class I (US FDA UDI)

by Reliance Orthodontic Products, Inc.

Identity

Trade Name: Spatula FDA UDI
Generic Name: Dental material injection cannula, single-use FDA UDI
Device Name: Plastic, sterilization-safe mixing tool for orthodontic adhesives FDA UDI
Model / Reference: 1SPATULA FDA UDI
Description: Plastic, sterilization-safe mixing tool for orthodontic adhesives FDA UDI

Identifiers

Catalog Number: 1SPATULA FDA UDI
Primary DI / UDI-DI: D7981SPATULA0 FDA UDI
FDA Product Code: KXR FDA UDI
GMDN Term: Dental material injection cannula, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental material injection cannula, single-use

Spatula by Reliance Orthodontic Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Reliance Orthodontic Products, Inc.

Sources (1)

FDA UDI 05d610da-9501-4dcb-8bcb-adbfda2dbf0a 36 fields · synced May 30, 2026