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Durabase
EUDAMEDFDA UDIClass I (EU MDR)
Ref Durabase Soft PackageModel Durabase Soft
Identity
- Trade Name
- Durabase EUDAMEDDurabase Soft - Pink FDA UDI
- Generic Name
- Dental impression tray material FDA UDI
- Device Name
- Durabase Soft Package EUDAMEDDenture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID) FDA UDI
- Model / Reference
- Durabase Soft EUDAMEDDurabase Soft Package EUDAMED1506 FDA UDI
- Description
- Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D9471506 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D9471506 EUDAMED
- FDA Product Code
- EBH FDA UDI
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
- GMDN Term
- Dental impression tray material FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3670 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone dental impression material
Durabase by Reliance Dental Manufacturing — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone dental impression material.
- Defend — Young Innovations, Inc. · Class II
- UPPER IMPRESSION TRAY (S) — Dental Expert · Class I
- Katalysator Paste 35 ml — DETAX GmbH & Co. KG · Class IIa
- Bonasil A+ Regular (FS) 50ml x 32 — DMP Dental Industry S.A. · Class I
- BISSNEHMEWACHS GELB (weich) — Gebdi Dental-Products GmbH · Class I
- Polysil Multipurpose Regular Set — Scican GmbH · Class II
- PERFECTO — CROWN DELTA CORP. · Class II
- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-D9471506 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 (2)
- EUDAMED d3ea0f8a-55eb-4b9f-ab64-f892871a342d 61 fields · synced Jul 15, 2026
- FDA UDI 73211b05-9eb4-451f-b118-61e096e4e608 34 fields · synced May 30, 2026