Identity
- Trade Name
- Digital Temp - B1 - 250g EUDAMEDDigital Temp B1 - 250g FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Digital Temp EUDAMEDSprintRay Digital Temp is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed temporary full single crowns; temporary partial crowns in anterior and posterior area, individual and fixed single temporary veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. FDA UDI
- Model / Reference
- SRI-0204019 EUDAMEDFDA UDI
- Description
- SprintRay Digital Temp is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed temporary full single crowns; temporary partial crowns in anterior and posterior area, individual and fixed single temporary veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704987 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0204020H5 EUDAMED
- 510(k) Number
- K242559 FDA UDI
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q0102050101 TEMPORARY TEETH RESINS EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 250 Gram FDA UDI
Category: Dental appliance fabrication material, resin
Digital Temp B1 - 250g by Sprintray, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, resin.
- O-Cryl Self Curing Acrylic Shade White X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S A · Class II
- PREMIUM — Lang Dental Manufacturing Company, Inc. · Class II
- Axcent Acrylics — GARRECO, LLC · Class II
- smartrepair A2 — DETAX GmbH & Co. KG · Class IIa
- BASIS HI — YAMAHACHI DENTAL MFG., CO. · Class II
- vynacron dental resins — VYNACRON DENTAL RESINS, INC. · Class II
- HI-I® — FRICKE INTERNATIONAL, INC. · Class II
- FREEPRINT crown A1 500g — DETAX GmbH · Class II
Cleared under the same submission
K242559 also covers:
- Digital Temp A1 Single-Unit Capsule — Sprintray, Inc.
- Digital Temp A1 Single-Unit Capsule 3-Pack — Sprintray, Inc.
- Digital Temp A2 - 250g — Sprintray, Inc.
- Digital Temp A2 Single-Unit Capsule — Sprintray, Inc.
- Digital Temp A2 Single-Unit Capsule 3-Pack — Sprintray, Inc.
- Digital Temp B1 Single-Unit Capsule — Sprintray, Inc.
- Digital Temp B1 Single-Unit Capsule 3-Pack — Sprintray, Inc.
- Digital Temp Bleach - 250g — Sprintray, Inc.
- Digital Temp Bleach Single-Unit Capsule — Sprintray, Inc.
- Digital Temp Bleach Single-Unit Capsule 3-Pack — Sprintray, Inc.
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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sprintray, Inc.
Sources (2)
- FDA UDI d57924be-077c-479e-aeee-9cd0ae34f118 36 fields · synced Jul 28, 2026
- EUDAMED fd1e5fc2-3738-43b7-afeb-50d3d88d538e 61 fields · synced Jul 28, 2026