Identity
- Trade Name
- BUTLER® FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- MONSTERZ White liquid Fluoride Varnish, 5% w/w Sodium Fluoride FDA UDI
- Model / Reference
- 1219 FDA UDI
- Description
- MONSTERZ White liquid Fluoride Varnish, 5% w/w Sodium Fluoride FDA UDI
Identifiers
- Catalog Number
- P FDA UDI
- Primary DI / UDI-DI
- 10070942002025 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Butler® by Sunstar Americas, 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 |
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Manufacturer
- Manufacturer
- Sunstar Americas, Inc.
Sources (1)
- FDA UDI a704d09b-5345-46fe-9c39-fc0ed0448c0f 35 fields · synced May 30, 2026