Identity
- Trade Name
- OnX Tough 2 A2 Single-unit Capsule 3-Pack FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. FDA UDI
- Model / Reference
- SRI-0204054 FDA UDI
- Description
- SprintRay OnX Tough 2 is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850070544290 FDA UDI
- 510(k) Number
- K230445 FDA UDI
- FDA Product Code
- EBI FDA UDIPZY FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI872.3590 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 — 12 Milliliter FDA UDI
Category: Dental appliance fabrication material, resin
OnX Tough 2 A2 Single-unit Capsule 3-Pack 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.
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Cleared under the same submission
K230445 also covers:
- OnX Tough 2 - A1 - 3kg — Sprintray, Inc.
- OnX Tough 2 - A2 - 3kg — Sprintray, Inc.
- OnX Tough 2 - B1 - 3kg — Sprintray, Inc.
- OnX Tough 2 - B1 - Single-unit Capsule 3-Pack — Sprintray, Inc.
- OnX Tough 2 - Bleach - 3kg — Sprintray, Inc.
- OnX Tough 2 - Hollywood White - 3kg — Sprintray, Inc.
- OnX Tough 2 - Hollywood White - Single-unit Capsule 3-Pack — Sprintray, Inc.
- OnX Tough 2 A1 Single-unit Capsule 3-Pack — Sprintray, Inc.
- OnX Tough 2 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 6d0d12dc-dba1-4ce0-a9f5-519908c7a0ae 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026