Identity
- Trade Name
- APEX Teeth B1 EUDAMEDSprintRay Apex Teeth - B1 - 500 g FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- APEX Teeth EUDAMEDAPEX Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures. This material is an alternative to traditional denture teeth material. FDA UDI
- Model / Reference
- SRI-0202159 EUDAMEDFDA UDI
- Description
- APEX Teeth is a light-curable polymerizable resin intended to be used to fabricate artificial teeth for full and partial removable dentures. This material is an alternative to traditional denture teeth material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704710 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202157HK EUDAMED
- FDA Product Code
- PZY FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 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
Yes
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 — 500 Gram FDA UDI
APEX Teeth B1 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-0202157HK | 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 e505ac5c-ba1e-4694-953d-11a81803f848 61 fields · synced Jun 18, 2026
- FDA UDI 067b76b8-8bd8-4737-9f46-d2ecbe8e5b9e 36 fields · synced May 30, 2026