Duns Number:808371371
Device Description: Dental City Earloop Masks 4 PLY Super Soft Cobalt Blue
Catalog Number
-
Brand Name
Dental City
Version/Model Number
25-2053CB
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133070,K133070
Product Code
FXX
Product Code Name
Mask, Surgical
Public Device Record Key
4707cab9-e7f1-4d03-9743-2792b7569bb3
Public Version Date
October 18, 2021
Public Version Number
2
DI Record Publish Date
June 22, 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 | 289 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |