Duns Number:317654200
Device Description: Erkoflex, 2.00 mm, Ø 120 mm, bright pink. Thermoforming sheet material for the fabrication Erkoflex, 2.00 mm, Ø 120 mm, bright pink. Thermoforming sheet material for the fabrication of orthodontic and dental appliances.
Catalog Number
-
Brand Name
Erkoflex
Version/Model Number
584225
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
K200125
Product Code
KMY
Product Code Name
Positioner, Tooth, Preformed
Public Device Record Key
d0541bf2-6df9-471d-87c6-eccac2528047
Public Version Date
September 03, 2021
Public Version Number
1
DI Record Publish Date
August 26, 2021
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 | 166 |