Duns Number:532176000
Device Description: Thermoplastic pellets softens with a dip hot water to a pliable putty for immediate impres Thermoplastic pellets softens with a dip hot water to a pliable putty for immediate impressions,individual trays,bite registrations,night guards,extending walls,functional impressions,jig in implants.Colour White200Gr. jar
Catalog Number
455002
Brand Name
Perflex Thermofix
Version/Model Number
White
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
Yes
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
EBH
Product Code Name
Material, Impression Tray, Resin
Public Device Record Key
4bcf0618-a507-4999-aa2c-30c58d5f9245
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 25, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 133 |