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 0.5KG FDA UDI
- Model / Reference
- 4200008 EUDAMEDFDA UDI
- Description
- KeyOrtho IBT 0.5KG FDA UDI
Identifiers
- Catalog Number
- 4200008 FDA UDI
- Primary DI / UDI-DI
- ++H66842000081 EUDAMEDH66842000081 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
- Total Volume — 17.6 Fluid Ounce FDA UDIWeight — 0.5 Kilogram FDA UDI
KeyOrtho IBT by Keystone Industries — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++H6683DORTHO001KP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keystone Industries
- EUDAMED SRN
- US-MF-000020203
- Authorised Representative
- KEYSTONE Europe BV NL-AR-000010443
Sources (2)
- EUDAMED b57fddc2-b44c-43e3-8546-3815374e7170 61 fields · synced Jul 12, 2026
- FDA UDI 6df7bbd7-3ea9-48bb-b349-7528524e0651 37 fields · synced May 30, 2026