Duns Number:020417380
Device Description: Safco illusion Plus A1 Unit Dose Capsule .2g
Catalog Number
1020231
Brand Name
Safco Illusion Plus Composite
Version/Model Number
1020231
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
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
EBF
Product Code Name
MATERIAL, TOOTH SHADE, RESIN
Public Device Record Key
29b08b85-1884-4512-b4bf-d4fef69ebf2e
Public Version Date
June 25, 2019
Public Version Number
1
DI Record Publish Date
June 17, 2019
Package DI Number
D72310202315
Quantity per Package
50
Contains DI Package
D72310202313
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 600 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |