Identity
- Trade Name
- KeyGuide EUDAMEDKeyPrint FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 3D Resin for printed Dental Surgical Guides EUDAMEDKeyGuide 1 KG FDA UDI
- Model / Reference
- 4220001 EUDAMEDFDA UDI
- Description
- KeyGuide 1 KG FDA UDI
Identifiers
- Catalog Number
- 4220001 FDA UDI
- Primary DI / UDI-DI
- ++H66842200011 EUDAMEDH66842200011 FDA UDI
- Basic UDI-DI
- ++H6683DGUIDE0018H EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 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
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
KeyPrint by Keystone Industries — Class I — 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 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 070b21f8-b19c-4ba8-b0a9-b8909be8f22d 37 fields · synced Jun 18, 2026
- EUDAMED 28e1ef2d-3a7a-4267-a982-06f37df22e8e 61 fields · synced Jun 18, 2026