Identity
- Trade Name
- Pro-Form Soft EVA EUDAMEDProform FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Vacuum Forming Materials EUDAMED.080 Soft Eva (25) Clear 120mm Round FDA UDI
- Model / Reference
- 9597150R2 EUDAMEDFDA UDI
- Description
- .080 Soft Eva (25) Clear 120mm Round FDA UDI
Identifiers
- Catalog Number
- 9597150R2 FDA UDI
- Primary DI / UDI-DI
- ++H6689597150R21 EUDAMEDH6689597150R21 FDA UDI
- Basic UDI-DI
- ++H668VFM00158 EUDAMED
- FDA Product Code
- MQC FDA UDIEBH 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 EUDAMEDU FDA UDI
- Regulation Number
- 872.3670 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
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 U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Keystone Industries
Sources (2)
- FDA UDI 77def99b-b902-4005-9b3f-b08a9d87f59b 36 fields · synced Jul 9, 2026
- EUDAMED 70271342-695b-4606-9529-5675247186b9 61 fields · synced Jul 9, 2026