Identity
- Trade Name
- freeprint IBT 385 1000 g EUDAMEDfreeprint IBT 385 1000g FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Schienungsmaterial, dental, Zubehör EUDAMED
- Model / Reference
- 04249 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- +EDET042491 EUDAMEDEDET042491 FDA UDI
- Basic UDI-DI
- ++EDET07565 EUDAMED
- FDA Product Code
- EBH FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Dental impression tray, single-use 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
No
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
No
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
freeprint IBT 385 1000 g by DETAX GmbH & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++EDET07565 | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005995
Sources (2)
- EUDAMED dd932e9b-bba9-42d2-8b04-a1bb683d277e 61 fields · synced Oct 6, 2026
- FDA UDI f411d125-7417-44e6-a9ac-87a3925ae2c4 32 fields · synced May 26, 2026