SprintRay High Impact Denture Teeth - C2

FDA UDI

Class II (US FDA UDI)

by Sprintray, Inc.

Identity

Trade Name: SprintRay High Impact Denture Teeth - C2 FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: SprintRay High Impact Denture Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures. FDA UDI
Model / Reference: SRI-0202093 FDA UDI
Description: SprintRay High Impact Denture Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850039704345 FDA UDI
FDA Product Code: PZY FDA UDI
ELM FDA UDI
GMDN Term: Dental appliance fabrication material, resin FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3590 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

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 — 0.5 Liter FDA UDI

Category: Dental appliance fabrication material, resin

SprintRay High Impact Denture Teeth - C2 by Sprintray, 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: Sprintray, Inc.

Sources (1)

FDA UDI 0468ee8f-2fe9-44de-9ad4-286545f9a58e 36 fields · synced May 30, 2026