FDA UDI
In Commercial Distribution
🇺🇸 United States
KwikkModel ® SCAN
DI: ERDEKMK10881
·
Model: KMK1088
·
R-Dental Dentalerzeugnisse GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KwikkModel ® SCAN
- Primary DI
- ERDEKMK10881
- Version / Model
- KMK1088
- Catalog Number
- KMK1088
- Company Name
- R-Dental Dentalerzeugnisse GmbH
- Labeler DUNS
- 313956880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2019-04-10
- Public Version Status
- Update
- Public Device Record Key
- 30f2773a-116f-4807-9ae3-61b75fd571f0
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | Material, Impression | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ERDEKMK10881 | HIBCC |
Customer Contacts
- Phone
- +4940307070730
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius