SprintRay Standard Denture Base - Dark Pink

FDA UDI

Class II (US FDA UDI)

by Sprintray, Inc.

Identity

Trade Name: SprintRay Standard Denture Base - Dark Pink FDA UDI
Generic Name: Dental appliance fabrication material, resin FDA UDI
Device Name: SprintRay Standard Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. FDA UDI
Model / Reference: SRI-0202097 FDA UDI
Description: SprintRay Standard Denture Base is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850039704413 FDA UDI
510(k) Number: K220979 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Dental appliance fabrication material, resin 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

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

Dimensions & Sizes

Size: Total Volume — 1 Liter FDA UDI

Category: Dental appliance fabrication material, resin

SprintRay Standard Denture Base - Dark Pink by Sprintray, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental appliance fabrication material, resin.

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BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
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FREEPRINT crown A1 500g — DETAX GmbH · Class II

Cleared under the same submission

K220979 also covers:

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 f988caca-ab9f-46b8-80ab-63a463bef518 37 fields · synced May 30, 2026