Identity
- Trade Name
- APEX Base Original Pink EUDAMEDSprintRay Apex Base - Original Pink - 1 Kg FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- APEX Base EUDAMEDAPEX Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. FDA UDI
- Model / Reference
- SRI-0202154 EUDAMEDFDA UDI
- Description
- APEX Base resin is a light-curable polymerizable resin intended to be used for the fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional denture base material. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850039704666 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850039704SRI-0202153HB EUDAMED
- 510(k) Number
- K221678 FDA UDI
- FDA Product Code
- EBI 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
- 872.3760 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 — 1 Kilogram FDA UDI
APEX Base Original Pink 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-0202153HB | 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 8dfad673-895a-490e-8f14-e63d792da6d8 61 fields · synced May 30, 2026
- FDA UDI 84dfdbc9-e67a-4199-a8c8-cffdd3577bc0 37 fields · synced May 30, 2026