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KeyDentureTry-In
EUDAMEDFDA UDIClass I (EU MDR)
Ref 4200401Ref 4220401Ref 4220420Ref 4200420
Identity
- Trade Name
- KeyDentureTry-In EUDAMEDKeyPrint FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- 3D resin for printed Try-In Dentures EUDAMEDKeyDenture Try In, BL4, 1 KG FDA UDIKeyDenture Try In, A1, 0.5 KG FDA UDIKeyDenture Try In, BL4, 0.5 KG FDA UDIKeyDenture Try In, A1, 1 KG FDA UDI
- Model / Reference
- 4200401 EUDAMEDFDA UDI4220420 EUDAMEDFDA UDI4200420 EUDAMEDFDA UDI4220401 EUDAMEDFDA UDI
- Description
- KeyDenture Try In, BL4, 1 KG FDA UDIKeyDenture Try In, A1, 0.5 KG FDA UDIKeyDenture Try In, BL4, 0.5 KG FDA UDIKeyDenture Try In, A1, 1 KG FDA UDI
Identifiers
- Catalog Number
- 4220420 FDA UDI4200401 FDA UDI4200420 FDA UDI4220401 FDA UDI
- Primary DI / UDI-DI
- ++H66842004011 EUDAMED++H66842204011 EUDAMED++H66842204201 EUDAMED++H66842004201 EUDAMEDH66842204201 FDA UDIH66842004011 FDA UDIH66842004201 FDA UDIH66842204011 FDA UDI
- Basic UDI-DI
- ++H6683DTRYIN001QT EUDAMED
- FDA Product Code
- EBH 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
- 872.3670 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 UDIWeight — 0.5 Kilogram FDA UDITotal Volume — 17.6 Fluid Ounce FDA UDI
KeyDentureTry-In 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 | ++H6683DTRYIN001QT | 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 (8)
- EUDAMED 8b285eb9-f4b7-4e1b-8f2a-7b8e1b4a069f 61 fields · synced Aug 1, 2026
- FDA UDI 1214ee3c-7857-4227-9061-69813e065485 37 fields · synced May 29, 2026
- FDA UDI 7079ab02-a87c-45c8-8e8e-ed1105336f1c 37 fields · synced May 29, 2026
- FDA UDI 49856f13-a43b-4710-93b8-b735b4ea2c7c 37 fields · synced May 30, 2026
- FDA UDI edace4d0-5765-4322-8331-d178d8ccaae6 37 fields · synced May 30, 2026
- EUDAMED 43370e32-6dba-4cf6-8d56-ed2daee16b20 61 fields · synced Jul 9, 2026
- EUDAMED 3dfa463c-b422-4174-8532-8997c02ab85a 61 fields · synced Jul 10, 2026
- EUDAMED 339f5b54-552c-49c8-9712-36ace625de42 61 fields · synced Aug 1, 2026