EasySoft Liner Starter Kit

FDA UDI

Class II (US FDA UDI)

by Karlin Dental Distributors Inc

Identity

Trade Name: EasySoft Liner Starter Kit FDA UDI
Generic Name: Denture reliner, soft, professional FDA UDI
Device Name: 2 x 50 ml EasySoft Liner 1 x 50 ml EasySoft Liner Sealant 1 x 10 ml EasySoft Liner Adhesive (mixing tips, brushes, polishing discs and mandrel are all used outside of mouth and are not medical devices) FDA UDI
Model / Reference: 0501 FDA UDI
Description: 2 x 50 ml EasySoft Liner 1 x 50 ml EasySoft Liner Sealant 1 x 10 ml EasySoft Liner Adhesive (mixing tips, brushes, polishing discs and mandrel are all used outside of mouth and are not medical devices) FDA UDI

Identifiers

Primary DI / UDI-DI: 00627843583769 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Denture reliner, soft, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 10 Milliliter FDA UDI
Total Volume — 50 Milliliter FDA UDI

Category: Denture reliner, soft, professional

EasySoft Liner Starter Kit by Karlin Dental Distributors Inc — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Karlin Dental Distributors Inc

Sources (1)

FDA UDI 3950272a-9c52-481f-812f-45538476205b 36 fields · synced Jun 8, 2026