Duns Number:277657631
Device Description: Expasyl is a paste for temporary gingival retraction that ensures separation of the margin Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of the sulcus
Catalog Number
-
Brand Name
ACTEON
Version/Model Number
EXPASYL EXACT
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
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
K050180,K050180,K050180,K050180
Product Code
MVL
Product Code Name
Cord, Retraction
Public Device Record Key
8f8f0617-8b14-4554-9b74-36d055756dce
Public Version Date
March 12, 2020
Public Version Number
1
DI Record Publish Date
March 04, 2020
Package DI Number
03760243007170
Quantity per Package
20
Contains DI Package
03760243001048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 7 |