Henry Schein

FDA UDI

Class II (US FDA UDI)

by Henry Schein, Inc.

Identity

Trade Name: Henry Schein FDA UDI
Generic Name: Denture reliner, elastic, short-term FDA UDI
Device Name: Chairside Reline Material Pack Ea FDA UDI
Model / Reference: 1005646 FDA UDI
Description: Chairside Reline Material Pack Ea FDA UDI

Identifiers

Catalog Number: 1005646 FDA UDI
Primary DI / UDI-DI: 00304040029435 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Denture reliner, elastic, short-term 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

Yes

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 — 110 Milliliter FDA UDI
Weight — 100 Gram FDA UDI

Category: Denture reliner, elastic, short-term

Henry Schein by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Denture reliner, elastic, short-term.

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ProTech UBAR — PROTECH PROFESSIONAL PRODUCTS, INC. · Class II
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ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, INC. · Class II
ProTech Plus Hard Reline and Repair Acrylic — PROTECH PROFESSIONAL PRODUCTS, 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: Henry Schein, Inc.

Sources (1)

FDA UDI d8a734f1-3ce8-4483-aeff-c96ba3027f96 36 fields · synced May 30, 2026