Duns Number:448015938
Device Description: Empress Direct Ref. 10x0.2g A2 Enamel, Empress Direct Ref. 10x0.2g A2 Dentin, Empress Dire Empress Direct Ref. 10x0.2g A2 Enamel, Empress Direct Ref. 10x0.2g A2 Dentin, Empress Direct Ref. 10x0.2g A3 Dentin, Empress Direct Ref. 10x0.2g A3 Enamel, Empress Direct Ref. 10x0.2g Trans 30, Empress Direct Ref. 10x0.2g Opal, Empress Direct Effect Ref. 1x1.8g Opal, SPR Empress Direct Effect Color ocker, SPR Empress Direct Effect Color weiss, AdheSE Universal 0.5ml VivaPen (BULK)
Catalog Number
740800AN
Brand Name
IPS Empress Direct
Version/Model Number
740800AN
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
695d0b99-4475-4339-9d07-8a8efefb438e
Public Version Date
March 17, 2022
Public Version Number
2
DI Record Publish Date
July 28, 2020
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 | 131 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12768 |