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Xplora Silicona Adicion Putty Soft Regular Set
EUDAMEDClass I (EU MDR)
Ref 3641
Identity
- Trade Name
- XPLORA SILICONA ADICION PUTTY SOFT REGULAR SET EUDAMED
- Device Name
- Ventura dental impression material EUDAMED
- Model / Reference
- 3641 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435316136419 EUDAMED
- Basic UDI-DI
- 84353161DM014A79 EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Xplora Silicona Adicion Putty Soft Regular Set by Madespa, S.a. — 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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- 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 (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 | 84353161DM014A79 | Class I | Active |
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Manufacturer
- Manufacturer
- Madespa, S.a.
- EUDAMED SRN
- ES-MF-000003915
Sources (1)
- EUDAMED 3453096d-ce0b-40dd-8a66-ce9626e34896 61 fields · synced Aug 2, 2026