Identity
- Trade Name
- SoundSeal FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- FG-008-00002 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- GW-SYS-SOSE FDA UDI
- Primary DI / UDI-DI
- 00858395006356 FDA UDI
- 510(k) Number
- K022522 FDA UDI
- FDA Product Code
- EIE FDA UDI
- GMDN Term
- Rubber dam, non-latex FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rubber dam, non-latex
SoundSeal by Sonendo, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sonendo, Inc.
Sources (1)
- FDA UDI 02c3e420-a16a-4966-a45b-735010c65aff 37 fields · synced Jun 8, 2026