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Wax Spacer
EUDAMEDClass I (EU MDR)
Ref DBSH0001-1Ref DBSH0001-3Ref DBSH0001-MRef DBSH0001-2
Identity
- Trade Name
- Wax Spacer EUDAMED
- Device Name
- Dentalwachse EUDAMED
- Model / Reference
- DBSH0001-1 EUDAMEDDBSH0001-3 EUDAMEDDBSH0001-M EUDAMEDDBSH0001-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +D991DB0112F EUDAMED+D991DB0132H EUDAMED+D991DB01M2- EUDAMED+D991DB0122G EUDAMED
- Basic UDI-DI
- ++D991DW82435NG EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Silicone dental impression material
Wax Spacer by MORSA Wachswarenfabrik Sallinger GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone dental impression material.
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- Bona-Bite 50ml x 32 — DMP Dental Industry S.A. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++D991DW82435NG | Class I | Active |
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Manufacturer
- Manufacturer
- MORSA Wachswarenfabrik Sallinger GmbH
- EUDAMED SRN
- DE-MF-000028586
Sources (4)
- EUDAMED ca14bdfa-c972-48e8-8590-294cc8de0ec6 61 fields · synced Oct 7, 2026
- EUDAMED 141a6252-28f1-4e91-b660-0600f09262d8 61 fields · synced May 17, 2026
- EUDAMED ba875ffb-1de1-4f69-9e6b-c99fb4dad34e 61 fields · synced May 18, 2026
- EUDAMED abbf9adb-acdc-41d7-b221-7496ee2e9637 61 fields · synced May 18, 2026