Bosworth Trusoft

FDA UDI

Class II (US FDA UDI)

by Harry J. Bosworth Co.

Identity

Trade Name: Bosworth Trusoft FDA UDI
Generic Name: Denture reliner, soft, professional FDA UDI
Device Name: 1 Qt PEMA Reline Liquid FDA UDI
Model / Reference: 0921258 FDA UDI
Description: 1 Qt PEMA Reline Liquid FDA UDI

Identifiers

Catalog Number: 0921258 FDA UDI
Primary DI / UDI-DI: H66809212581 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Total Volume — 32 Fluid Ounce FDA UDI
Total Volume — 946 Milliliter FDA UDI

Category: Denture reliner, soft, professional

Bosworth Trusoft by Harry J. Bosworth Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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EasySoft Liner Starter Kit — Karlin Dental Distributors Inc · Class II

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: Harry J. Bosworth Co.

Sources (1)

FDA UDI d62bc8e3-8a83-4c5d-b062-637ed0d56e26 37 fields · synced Jun 8, 2026