Spreaders

FDA UDI

Class I (US FDA UDI)

by DiaDent Group International

Identity

Trade Name: SPREADERS FDA UDI
Generic Name: Manual endodontic filling material spreader FDA UDI
Device Name: Spreaders are used for lateral condensation of root canal fillings. FDA UDI
Model / Reference: 25m/m 55 FDA UDI
Description: Spreaders are used for lateral condensation of root canal fillings. FDA UDI

Identifiers

Catalog Number: 520-211 FDA UDI
Primary DI / UDI-DI: 08806383535151 FDA UDI
FDA Product Code: EKK FDA UDI
GMDN Term: Manual endodontic filling material spreader 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

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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual endodontic filling material spreader

Spreaders by DiaDent Group International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EZ-Fill Bi-Directional Spiral — ESSENTIAL DENTAL SYSTEMS, INC. · Class I
Pomee — POMEE CORPORATION · Class I
Premier SPREADERS — PREMIER DENTAL PRODUCTS COMPANY · Class I
SPREADER — KLS-Martin L.P. · Class I

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: DiaDent Group International

Sources (1)

FDA UDI e8901d46-4b47-47d2-ae92-fa14e7746632 34 fields · synced May 30, 2026