DURALAY – Temporary Crown & Bridge Kit

FDA UDIEUDAMED

Class I (US FDA UDI)

by Reliance Dental Manufacturing

Identity

Trade Name: DURALAY – Temporary Crown & Bridge Kit FDA UDI
Generic Name: Dental impression tray material FDA UDI
Device Name: TEMPORARY CROWN AND BRIDGE /4 - 2 OZ. POWDER / 2 - 2 OZ. LIQUID (56 GR POWDER / 60 ML LIQUID) 1 each #62 Powder, #65 Powder, #69 Powder, #77 Powder FDA UDI
Model / Reference: 2503 FDA UDI
Description: TEMPORARY CROWN AND BRIDGE /4 - 2 OZ. POWDER / 2 - 2 OZ. LIQUID (56 GR POWDER / 60 ML LIQUID) 1 each #62 Powder, #65 Powder, #69 Powder, #77 Powder FDA UDI

Identifiers

Primary DI / UDI-DI: D9472503 FDA UDI
FDA Product Code: EBH FDA UDI
GMDN Term: Dental impression tray material FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3670 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental impression tray material

DURALAY – Temporary Crown & Bridge Kit by Reliance Dental Manufacturing — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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OpaTray — OPA DENTAL, LLC · Class I
SR Ivolen — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class I
JET TRAY POWDER — Lang Dental Manufacturing Company, Inc. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Reliance Dental Manufacturing

Sources (2)

FDA UDI 86d1feb1-732c-4cf3-8994-9d2239a5766f 34 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 3, 2026