Identity
- Trade Name
- Dura Rely-A-Soft Economy Package - Pink FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- Long term denture relining material/PACKAGE 454 GR POWDER / 2-8 OZ. LIQUID / 2- 1 OZ. SEALER FDA UDI
- Model / Reference
- 1706 FDA UDI
- Description
- Long term denture relining material/PACKAGE 454 GR POWDER / 2-8 OZ. LIQUID / 2- 1 OZ. SEALER FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9471706 FDA UDI
- 510(k) Number
- K852741 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Dental appliance fabrication material, thermoplastic
Dura Rely-A-Soft Economy Package - Pink by Reliance Dental Manufacturing — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, thermoplastic.
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- G-CAM — GRAPHENANO DENTAL SL. · Class II
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Cleared under the same submission
K852741 also covers:
- Dura Conditioner Bulk Package - Pink — Reliance Dental Manufacturing
- Dura Conditioner Bulk Package - White — Reliance Dental Manufacturing
- Dura Conditioner Complete Package - Pink — Reliance Dental Manufacturing
- Dura Rely-A-Soft Complete Package - Clear — Reliance Dental Manufacturing
- Dura Rely-A-Soft Economy Package - Clear — Reliance Dental Manufacturing
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reliance Dental Manufacturing
Sources (2)
- FDA UDI 44fc29c5-d035-488f-9545-2bbdef233ff7 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 22, 2026