Identity
- Trade Name
- KeyOrtho IBT EUDAMEDKeyPrint FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 3D Resin for printing of Indirect Bonding Trays EUDAMEDKeyOrtho IBT 1KG FDA UDI
- Model / Reference
- 4220008 EUDAMEDFDA UDI
- Description
- KeyOrtho IBT 1KG FDA UDI
Identifiers
- Catalog Number
- 4220008 FDA UDI
- Primary DI / UDI-DI
- ++H66842200081 EUDAMEDH66842200081 FDA UDI
- Basic UDI-DI
- ++H6683DORTHO001KP EUDAMED
- FDA Product Code
- QJJ 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
- 872.5410 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
- Weight — 1 Kilogram FDA UDITotal Volume — 35.3 Fluid Ounce 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 32525e22-dfcd-467b-bbe7-d4eac199f5c2 37 fields · synced Jun 19, 2026
- EUDAMED 24aa9fd9-0a7f-41d7-80d7-3b7a18304a94 61 fields · synced Jun 19, 2026