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KeySplint Soft for HeyGears
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 4200005Ref 4220005
Identity
- Trade Name
- KeySplint Soft EUDAMEDKeySplint Soft for HeyGears FDA UDIKeyPrint FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 3D Resin for printing soft splints EUDAMEDKeySplint Soft for HeyGears 1 kg FDA UDIKeySplint Soft 1 kg FDA UDIKeySplint Soft 0.5 kg sample FDA UDI
- Model / Reference
- 4220005 EUDAMEDFDA UDI4200005 EUDAMEDFDA UDI4220115 FDA UDI
- Description
- KeySplint Soft for HeyGears 1 kg FDA UDIKeySplint Soft 1 kg FDA UDIKeySplint Soft 0.5 kg sample FDA UDI
Identifiers
- Catalog Number
- 4220115 FDA UDI4220005 FDA UDI4200005 FDA UDI
- Primary DI / UDI-DI
- ++H66842000051 EUDAMED++H66842200051 EUDAMEDH66842201151 FDA UDIH66842200051 FDA UDIH66842000051 FDA UDI
- Basic UDI-DI
- B-++H66842000051 EUDAMEDB-++H66842200051 EUDAMED
- FDA Product Code
- KMY FDA UDIMQC 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 EUDAMEDClass I FDA UDIU 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
- Weight — 1 Kilogram FDA UDITotal Volume — 35.3 Fluid Ounce FDA UDITotal Volume — 17.6 Fluid Ounce FDA UDIWeight — 0.5 Kilogram FDA UDI
Category: Dental appliance fabrication material, resin
KeySplint Soft for HeyGears 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 (5)
- FDA UDI f01c74da-9c13-4c88-bde7-f7757586ae55 37 fields · synced Jul 23, 2026
- FDA UDI 025f7638-425f-48c4-8608-bdc97b58e688 37 fields · synced May 30, 2026
- FDA UDI 20dc5e63-a29e-4739-ad94-15d9787abc76 37 fields · synced May 30, 2026
- EUDAMED 21c8ec29-644d-494d-981a-5e9e3997f511 61 fields · synced Jul 15, 2026
- EUDAMED e5b15767-52a4-4dc9-b803-c7b030e4438e 61 fields · synced Jul 23, 2026