Identity
- Trade Name
- Aqua-Prep F FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Aqua-Prep F 6ml Bottle Pkg FDA UDI
- Model / Reference
- B-2822P FDA UDI
- Description
- Aqua-Prep F 6ml Bottle Pkg FDA UDI
Identifiers
- Catalog Number
- B-2822P FDA UDI
- Primary DI / UDI-DI
- D757B2822P1 FDA UDI
- 510(k) Number
- K961822 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
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
Yes
FDA UDI
Aqua-Prep F by Bisco 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
- Bisco Inc.
Sources (1)
- FDA UDI ba6f0e24-e5d0-4535-8f83-872e86283076 38 fields · synced May 30, 2026