Duns Number:030479000
Device Description: PERFECTO CAD-CAM FAST SET CARTRIDGE
Catalog Number
DW99
Brand Name
PERFECTO
Version/Model Number
DW99
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)
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
3560fcd8-e920-41d0-b2ca-30d279fcfc22
Public Version Date
May 28, 2018
Public Version Number
1
DI Record Publish Date
April 25, 2018
Package DI Number
10818524020315
Quantity per Package
2
Contains DI Package
00818524020318
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
KIT
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 15 |
2 | A medical device with a moderate to high risk that requires special controls. | 46 |