PolyCast

FDA UDI

Class II (US FDA UDI)

by Harvest Dental Products Llc

Identity

Trade Name: PolyCast FDA UDI
Generic Name: Temporary dental crown/bridge resin FDA UDI
Device Name: PolyCast Red 40mm Inlab Block FDA UDI
Model / Reference: 70054-40-3 FDA UDI
Description: PolyCast Red 40mm Inlab Block FDA UDI

Identifiers

Primary DI / UDI-DI: D870700544031 FDA UDI
FDA Product Code: EBG FDA UDI
GMDN Term: Temporary dental crown/bridge resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Temporary dental crown/bridge resin

PolyCast by Harvest Dental Products Llc — 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: Harvest Dental Products Llc

Sources (1)

FDA UDI 86c5e362-01fd-4b59-81a5-75f2a218b305 34 fields · synced May 30, 2026