Identity
- Trade Name
- Waterpik Barrier Dentin Sealant FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- Cavity varnish, coronal sealant for endodontic procedures, and short-term protectant for exposed root surfaces. FDA UDI
- Model / Reference
- 042305-000 FDA UDI
- Description
- Cavity varnish, coronal sealant for endodontic procedures, and short-term protectant for exposed root surfaces. FDA UDI
Identifiers
- Catalog Number
- 042305-000 FDA UDI
- Primary DI / UDI-DI
- D686423053 FDA UDI
- 510(k) Number
- K852756 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental cavity varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Total Volume — 15 Milliliter FDA UDI
Waterpik Barrier Dentin Sealant by Water Pik, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Water Pik, Inc.
Sources (1)
- FDA UDI 4570f0e7-8a1a-47fd-8389-e936fdce4fa0 39 fields · synced May 30, 2026