Duns Number:436661136
Device Description: ENAMEL PLUS TEMP INTRODUCTORY KIT- 1 TEMPL Self Curing 100 ml Liquid- 1 TEMP50BLUE, BLUE 5 ENAMEL PLUS TEMP INTRODUCTORY KIT- 1 TEMPL Self Curing 100 ml Liquid- 1 TEMP50BLUE, BLUE 50G POWDER- 1 TEMP50UD2, UD2 50g POWDER- 1 TEMP50UD3, UD3 50g POWDER- 1 TEMP50UD3,5 UD3.5 50g POWDER- 1 TEMP50UD4, UD4 50g POWDER- 1 TEMP50UE2, UE2 50g POWDER
Catalog Number
TEMP1N
Brand Name
Enamel Plus Temp ®
Version/Model Number
TEMP1N
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103474
Product Code
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
db908a51-b11c-440a-a2a1-9e826ce2cec9
Public Version Date
December 10, 2021
Public Version Number
1
DI Record Publish Date
December 02, 2021
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 | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 231 |