Identity
- Trade Name
- Pro-Form Splint Material EUDAMEDProform FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Pro Splint EUDAMED.040 Pro Splint 25Ea 120mm Round FDA UDI
- Model / Reference
- 9640961R2 EUDAMEDFDA UDI
- Description
- .040 Pro Splint 25Ea 120mm Round FDA UDI
Identifiers
- Catalog Number
- 9640961R2 FDA UDI
- Primary DI / UDI-DI
- ++H6689640961R21 EUDAMEDH6689640961R21 FDA UDI
- Basic UDI-DI
- B-++H6689640961R21 EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5525 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, thermoplastic
Proform by Keystone Industries — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keystone Industries
Sources (2)
- FDA UDI d6b63eed-dcdd-41ce-939e-6ee0b5e5d45f 36 fields · synced Jul 19, 2026
- EUDAMED be75c605-24f6-48b8-91d1-6ab963f33290 61 fields · synced Jul 19, 2026