Identity
- Trade Name
- KwikkModel ® SCAN FDA UDI
- Generic Name
- Silicone dental impression material FDA UDI
- Device Name
- KwikkModel ® SCAN is a precision impression material based on vinyl polysiloxane (VPS). The grey A-silicone is a highly flowable, thixotropic, fast setting precision impression material (model material) with fine detail reproduction, high dimension stability and a high final hardness. KwikkModel ® SCAN is used for pouring impressions extraorally to get an A-silicone model of cavities or teeth (instead of die). This A-silicone-model is the scan-model which can be used for optical scanning. It guarantees an excellent precision without any shrinkage. The product is available in a standard 50 ml auto-mixing cartridge plus 6 mixing cannulas and 6 Intra-Oral-Tips. It can be dispensed with a commercial dispenser. FDA UDI
- Model / Reference
- KMK1088 FDA UDI
- Description
- KwikkModel ® SCAN is a precision impression material based on vinyl polysiloxane (VPS). The grey A-silicone is a highly flowable, thixotropic, fast setting precision impression material (model material) with fine detail reproduction, high dimension stability and a high final hardness. KwikkModel ® SCAN is used for pouring impressions extraorally to get an A-silicone model of cavities or teeth (instead of die). This A-silicone-model is the scan-model which can be used for optical scanning. It guarantees an excellent precision without any shrinkage. The product is available in a standard 50 ml auto-mixing cartridge plus 6 mixing cannulas and 6 Intra-Oral-Tips. It can be dispensed with a commercial dispenser. FDA UDI
Identifiers
- Catalog Number
- KMK1088 FDA UDI
- Primary DI / UDI-DI
- ERDEKMK10881 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Silicone dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
KwikkModel ® SCAN by R-Dental Dentalerzeugnisse GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- R-Dental Dentalerzeugnisse GmbH
Sources (1)
- FDA UDI 30f2773a-116f-4807-9ae3-61b75fd571f0 36 fields · synced Jun 8, 2026