Duns Number:202781316
Device Description: Kit Contains:6 x MiTi Heavy Body VPS Impression Material,1 x MiTi Light Body VPS Impressio Kit Contains:6 x MiTi Heavy Body VPS Impression Material,1 x MiTi Light Body VPS Impression Material,18 x 88 mm Heavy Body Teal Mixing Tips,18 x 70 mm Light Body Yellow Mixing Tips,18 Intraoral Tips,18 MiTi Posterior Mesh Bite Trays
Catalog Number
-
Brand Name
Posterior Crown and Bridge Impression System Kit
Version/Model Number
627843379591
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
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
da79f592-584c-48a7-88b2-e575fd9f0f3b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 26, 2018
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. | 3 |