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Ormaplus Neo Bite 2x50 Ml + 12 Mixing Tips
EUDAMEDClass I (EU MDR)
Ref M3040-N2Model Addition curing silicones for dental impressions
Identity
- Trade Name
- ORMAPLUS NEO BITE 2X50 ML + 12 MIXING TIPS EUDAMED
- Model / Reference
- Addition curing silicones for dental impressions EUDAMEDM3040-N2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056640082397 EUDAMED
- Basic UDI-DI
- 8056640SILA5R EUDAMED
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Ormaplus Neo Bite 2x50 Ml + 12 Mixing Tips by Major Prodotti Dentari S.p.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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- 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 | 8056640SILA5R | Class I | Active |
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Manufacturer
- Manufacturer
- Major Prodotti Dentari S.p.A.
- EUDAMED SRN
- IT-MF-000024700
Sources (1)
- EUDAMED 20745368-bf8d-4dfc-b60d-411e52a3adba 61 fields · synced Aug 2, 2026