Identity
- Trade Name
- Bonascan Putty (RS) 400g+400g EUDAMEDBONASCAN PUTTY FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- Addition Curing Silicone Impression Material EUDAMEDAddition curing vinyl polysiloxane impression material, scannable FDA UDI
- Model / Reference
- 210124800 EUDAMEDRegular Set, 400g Base + 400g Catalyst FDA UDI
- Description
- Addition curing vinyl polysiloxane impression material, scannable FDA UDI
Identifiers
- Catalog Number
- 210124800 FDA UDI
- Primary DI / UDI-DI
- 05206569001082 EUDAMEDFDA UDI
- Basic UDI-DI
- 5206569DSIL22SD EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020102 DENTAL IMPRESSION VINYLSILOXANS EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Greece 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
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Category: Silicone dental impression material
Bonascan Putty by Dmp Dental Industry S.a. — Class II — MDR, FDA UDI — listed in FDA GUDID, 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 (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 |
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Manufacturer
- Manufacturer
- Dmp Dental Industry S.a.
Sources (2)
- FDA UDI 28aa19ea-d91a-441d-80af-8b5cf7e6d433 36 fields · synced Jul 8, 2026
- EUDAMED 015ea4a9-3c8d-43a7-96ea-015b48a486d0 61 fields · synced Jun 18, 2026