Duns Number:789664455
Device Description: Olympian M is used for cementating temporary crowns and splints. Retention of temporary cr Olympian M is used for cementating temporary crowns and splints. Retention of temporary crowns, sealing dressing in teeth during root canal therapy procedures.Trial cementation of permanent restorations prior to final insertion.Testing of interproximal contacts prior to final placement.
Catalog Number
0003
Brand Name
Olympian-M Temporary Cement, Syringe Part B
Version/Model Number
0003
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"
Yes
For Single-Use
Yes
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
EMA
Product Code Name
Cement, Dental
Public Device Record Key
155415a6-cb26-4d91-84ab-7b49ecf65238
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 02, 2016
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 59 |