Identity
- Trade Name
- Digital Temp A2 Single-Unit Capsule FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 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
- Model / Reference
- SRI-0204072 FDA 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
- 00850070544092 FDA UDI
- 510(k) Number
- K242559 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Dental appliance fabrication material, 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Total Volume — 4 Milliliter FDA UDI
Category: Dental appliance fabrication material, resin
Digital Temp A2 Single-Unit Capsule 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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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 3-Pack — Sprintray, Inc.
- Digital Temp B1 - 250g — 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 (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 6bb84c3b-a470-4669-8edc-81a5c95f68bb 36 fields · synced Jun 1, 2026