Identity
- Trade Name
- DuraLock® PLUS Impression Trays EUDAMEDFDA UDI
- Generic Name
- Dental impression tray, reusable FDA UDI
- Device Name
- Dental Impression Material Trays EUDAMEDDuraLock® PLUS Impression Tray - Size: 6 Extra Large, PURPLE Lower FDA UDI
- Model / Reference
- 640-056 EUDAMEDFDA UDI
- Description
- DuraLock® PLUS Impression Tray - Size: 6 Extra Large, PURPLE Lower FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707099411 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190707O2ImpressionTrayC8 EUDAMED
- Unit of Use DI
- 10190707099418 EUDAMED
- FDA Product Code
- EHY FDA UDI
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
- GMDN Term
- Dental impression tray, reusable 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
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
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
No
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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Also classified as Dental impression tray, single-use.
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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 | 0190707O2ImpressionTrayC8 | 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 b1a81529-6035-495f-8755-f0a12a270e65 61 fields · synced Jun 18, 2026
- FDA UDI b17196be-d43d-42a3-93aa-69c17b51146e 33 fields · synced May 30, 2026