Identity
- Trade Name
- Ceramic Crown A2 EUDAMEDSprintRay Ceramic Crown - A2 FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Ceramic Crown EUDAMEDIntended for the fabrication of individual and fixed definitive full single crowns, definitive partial crowns, individual and fixed single veneers, and artificial teeth for dental prostheses. FDA UDI
- Model / Reference
- SRI-0202086 EUDAMEDFDA UDI
- Description
- Intended for the fabrication of individual and fixed definitive full single crowns, definitive partial crowns, individual and fixed single veneers, and artificial teeth for dental prostheses. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704437 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202057HE EUDAMED
- 510(k) Number
- K222623 FDA UDI
- FDA Product Code
- EBF FDA UDIEBI FDA UDIELM FDA UDI
- EMDN Code
- Q01020502 PRE-FORMED DENTAL CROWNS EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3760 FDA UDI872.3590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 0.25 Liter FDA UDI
Ceramic Crown A2 by Sprintray, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0850039704SRI-0202057HE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sprintray Inc.
- EUDAMED SRN
- US-MF-000036081
- Authorised Representative
- SprintRay Europe GmbH DE-AR-000033436
Sources (2)
- EUDAMED 808aa0e2-9ed2-41ff-a17a-c39cf5af5f38 61 fields · synced Jul 9, 2026
- FDA UDI a8328f42-f7a5-47ed-b580-1d30ba08678e 37 fields · synced May 30, 2026