Identity
- Trade Name
- HurriSeal Dentin Desensitizer 12mL FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- 12mL bottle - dentin desensitizing liquid formula. FDA UDI
- Model / Reference
- 12mL bottle FDA UDI
- Description
- 12mL bottle - dentin desensitizing liquid formula. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 01723797697824 FDA UDI
- 510(k) Number
- K973002 FDA UDI
- FDA Product Code
- KLE FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3200 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
HurriSeal Dentin Desensitizer 12mL by Beutlich Pharmaceuticals, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Beutlich Pharmaceuticals, LLC
Sources (1)
- FDA UDI a63df029-6baf-430f-8df1-2a3d3ad57fed 37 fields · synced Jun 9, 2026