Identity
- Trade Name
- KeySplint Soft Clear for EnvisionTEC EUDAMEDKeySplint Soft for EnvisionTEC FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 3D Resin for printing soft splints EUDAMEDKeySplint Soft for EnvisionTEC 1 kg FDA UDI
- Model / Reference
- 4220105 EUDAMEDFDA UDI
- Description
- KeySplint Soft for EnvisionTEC 1 kg FDA UDI
Identifiers
- Catalog Number
- 4220105 FDA UDI
- Primary DI / UDI-DI
- ++H6684220105 EUDAMEDH66842201051 FDA UDI
- Basic UDI-DI
- B-++H6684220105 EUDAMED
- FDA Product Code
- MQC FDA UDIKMY FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA 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
No
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
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 — 35.3 Fluid Ounce FDA UDIWeight — 1 Kilogram FDA UDI
Category: Dental appliance fabrication material, resin
KeySplint Soft for EnvisionTEC by Keystone Industries — Class U — 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 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 108e3cb6-2e7c-4f87-8519-0c54f522c794 37 fields · synced Jun 18, 2026
- EUDAMED aea23309-ed24-49fa-aa70-58e3ec6b9a07 61 fields · synced Jun 18, 2026