Duns Number:113170088
Device Description: Faci Forms are intended for use as a mold for the creation of temporary, prosthetic compos Faci Forms are intended for use as a mold for the creation of temporary, prosthetic composite teeth. This is a pack of 5 medium and 5 large for the left side of the arch. Size #12.
Catalog Number
FFL
Brand Name
Faci Form
Version/Model Number
FFL
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
ECP
Product Code Name
Instrument, Ligature Tucking, Orthodontic
Public Device Record Key
627f5a2a-8a21-49aa-89fc-bac196de742b
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
August 08, 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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |