Duns Number:448015938
Device Description: IPS e.max CAD MO1 A14(L) blocks, LT A2 A14(L) blocks, LT A2 A16(L) blocks, Telio CAD LT A2 IPS e.max CAD MO1 A14(L) blocks, LT A2 A14(L) blocks, LT A2 A16(L) blocks, Telio CAD LT A2 A16(L) blocks, Virtual Extra Light Body fast, Multilink Hybrid Abutment HO 0, Liquid Strip, Monobond Etch&Prime, SR Connect, Monobond Plus, various accessories
Catalog Number
-
Brand Name
IPS E.MAX CAD
Version/Model Number
691203EN
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
NHA
Product Code Name
ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
Public Device Record Key
989068c8-f628-46c7-947c-8bfbf6545226
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
March 12, 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 | 131 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12768 |