Identity
- Trade Name
- DuraLock PLUS Impression Trays EUDAMEDDuraLock® PLUS FDA UDI
- Generic Name
- Dental impression tray, single-use FDA UDI
- Device Name
- Dental Impression Material Trays EUDAMEDDuraLock® PLUS IMPRESSION TRAYS LARGE UPPER-YELLOW 50PK FDA UDI
- Model / Reference
- 501-005U EUDAMEDFDA UDI
- Description
- DuraLock® PLUS IMPRESSION TRAYS LARGE UPPER-YELLOW 50PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190730088895 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190730OTImpressionTrayML EUDAMED
- Unit of Use DI
- 10190730088892 EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental impression tray, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6880 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental impression tray, single-use
DuraLock PLUS Impression Trays by Ortho Organizers, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0190730OTImpressionTrayML | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Organizers, Inc.
- EUDAMED SRN
- US-MF-000010061
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED c62e3faa-933f-4093-8ff1-18dbc311fa7c 61 fields · synced Jun 18, 2026
- FDA UDI b8164411-fe1c-446e-a50b-892212b1dfb9 33 fields · synced May 30, 2026