Duns Number:828894373
Device Description: Power bleaching: SoundSeal is used to protect the gingival during power bleaching procedu Power bleaching: SoundSeal is used to protect the gingival during power bleaching procedures.Block-out resin: SoundSeal is used to block out undercuts and gingival embrasures prior to taking impressions for crowns and bridges.Sandblasting: SoundSeal is used to mask and protect the gingiva during sandblasting. It is also placed on the areas of teeth to be masked during the sandblasting process.
Catalog Number
GW-SYS-SOSE
Brand Name
SoundSeal
Version/Model Number
FG-008-00002
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
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
K022522,K022522
Product Code
EIE
Product Code Name
Dam, Rubber
Public Device Record Key
02c3e420-a16a-4966-a45b-735010c65aff
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 16, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |