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Dura Rely-A-Soft
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Rely-A-Soft 4oz LiquidModel Dura Rely-A-SoftRef Rely-A-Soft Clear PackageRef Rely-A-Soft Pink PackageRef Rely-A-Soft 4oz Powder Clear
Identity
- Trade Name
- Dura Rely-A-Soft EUDAMEDDura Rely-A-Soft Complete Package - Pink FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Rely-A-Soft EUDAMEDLong term denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 1 OZ. SEALER (113 GR POWDER / 118 ML LIQUID) FDA UDI
- Model / Reference
- Dura Rely-A-Soft EUDAMEDRely-A-Soft 4oz Liquid EUDAMEDRely-A-Soft Clear Package EUDAMEDRely-A-Soft Pink Package EUDAMEDRely-A-Soft 4oz Powder Clear EUDAMED1701 FDA UDI
- Description
- Long term denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 1 OZ. SEALER (113 GR POWDER / 118 ML LIQUID) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9471703 EUDAMEDD9471701C EUDAMEDD9471701 EUDAMEDFDA UDID9471702C EUDAMED
- Basic UDI-DI
- ++D947DuraRelyASoft3T EUDAMED
- 510(k) Number
- K852741 FDA UDI
- FDA Product Code
- EBI FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Market of Registration
- Italy 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dura Rely-A-Soft by Reliance Dental Manufacturing — Class IIa — 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 | ++D947DuraRelyASoft3T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
- EUDAMED SRN
- US-MF-000041470
- Authorised Representative
- Kentzler-Kaschner Dental GmbH DE-AR-000006367
Sources (5)
- EUDAMED 62737253-2018-45c6-9466-2e323c09525d 61 fields · synced Sep 18, 2026
- EUDAMED fcf6edb5-3098-4f91-b06c-7bd7214b6220 61 fields · synced May 17, 2026
- EUDAMED 216eb39b-137a-42a9-98fd-244bd5ae6ee9 61 fields · synced May 18, 2026
- EUDAMED 0f292817-56ce-436e-86d7-4734473c1164 61 fields · synced May 18, 2026
- FDA UDI de1ae3b7-f0d6-4576-96de-99cfd7793472 35 fields · synced May 30, 2026