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Affinis
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 6776Model Impression Material
by Dent4You AG
Identity
- Trade Name
- AFFINIS PRECIOUS regular body Refill 2 x 50ml EUDAMEDAFFINIS FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- AFFINIS PRECIOUS regular body Refill 2 x 50ml FDA UDI
- Model / Reference
- 6776 EUDAMEDFDA UDIImpression Material EUDAMED
- Description
- AFFINIS PRECIOUS regular body Refill 2 x 50ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630243635207 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929ASIL190613K EUDAMED
- FDA Product Code
- ELW FDA UDI
- EMDN Code
- Q01020104 DENTAL IMPRESSION SILICONES EUDAMED
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Silicone dental impression material
Affinis by Dent4You AG — 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
- Dent4You AG
Sources (2)
- FDA UDI ac20b0b4-174a-40e3-ac64-9a3b1f52d9fc 33 fields · synced Jun 20, 2026
- EUDAMED fe187f75-3cb9-43d5-a0a1-b6ee3aa827f3 61 fields · synced Jun 20, 2026