Duns Number:113170088
Device Description: Faci Forms are intended for use as a mold for creating temporary prosthetic composite teet Faci Forms are intended for use as a mold for creating temporary prosthetic composite teeth. These 5 medium and 5 large forms for the right side of the arch Size 22.
Catalog Number
FFR
Brand Name
Faci Forms
Version/Model Number
FFR
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
078026f0-0aa3-4db0-8dae-8a2a2d82c489
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 |