Duns Number:688322841
Device Description: MD-Temp Plus is used for temporary filling material. It is supplied in a 20, 30 or 40g jar MD-Temp Plus is used for temporary filling material. It is supplied in a 20, 30 or 40g jar in either white (tooth-like) or pink (gum-like), and individually boxed. It is intended primarily as a temporary filling material for most cavities or damages but may be used by the dentist for other temporary restorations. MD-Temp plus is water-based temporary filling materials used for part of a tooth or multiple teeth. The curing reaction is the hydration reaction of the gypsum, and the semi-gypsum is cured as it is exposed to saliva or water in the oral cavity.
Catalog Number
-
Brand Name
MD-Temp Plus(White30g)
Version/Model Number
9389
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
EBG
Product Code Name
Crown And Bridge, Temporary, Resin
Public Device Record Key
ec3799fc-73c3-48db-a86a-bdd222d4b5a3
Public Version Date
October 29, 2021
Public Version Number
3
DI Record Publish Date
November 14, 2019
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 | 1335 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 284 |