Duns Number:119193803
Device Description: Like a third hand, the innovative Soft-Prop maintains an open field while holding a standa Like a third hand, the innovative Soft-Prop maintains an open field while holding a standard saliva ejector in the perfect position. Simply slide a saliva ejector into the prop before connecting to a valve. Or, used without a saliva ejector, the unique C-shape improves side access and visibility.Soft-Prop cradles an edentulous ridge in its smooth contoured groove to provide increased patient comfort and is ideal for use in lengthy procedures. Rigid polypropylene construction with soft elastomer pads allows for comfortable, secure bite-in.
Catalog Number
71-02413
Brand Name
Soft-Prop Mouth Prop
Version/Model Number
7102413
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BRW
Product Code Name
Protector, Dental
Public Device Record Key
d7ed2dfc-d9ca-4b57-852f-808bd97fb893
Public Version Date
October 05, 2018
Public Version Number
2
DI Record Publish Date
July 19, 2018
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |