Duns Number:313956880
Device Description: KwikkModel ® SCAN is a precision impression material based on vinyl polysiloxane (VPS). Th 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.
Catalog Number
KMK1088
Brand Name
KwikkModel ® SCAN
Version/Model Number
KMK1088
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ELW
Product Code Name
Material, Impression
Public Device Record Key
30f2773a-116f-4807-9ae3-61b75fd571f0
Public Version Date
April 10, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |