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VELLA 5% Sodium Fluoride Varnish Melon Case 12 Boxes 100
FDA UDIClass II (US FDA UDI)
by Preventech
Identity
- Trade Name
- VELLA 5% Sodium Fluoride Varnish Melon Case 12 Boxes 100 FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing FDA UDI
- Device Name
- VELLA 5% Sodium Fluoride Varnish Melon Case 12 Boxes 100 ea. 0.5mL unit dose packages FDA UDI
- Model / Reference
- 770085 FDA UDI
- Description
- VELLA 5% Sodium Fluoride Varnish Melon Case 12 Boxes 100 ea. 0.5mL unit dose packages FDA UDI
Identifiers
- Catalog Number
- 770085 FDA UDI
- Primary DI / UDI-DI
- D024770085 FDA UDI
- 510(k) Number
- K140350 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 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
No
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: Dental coating, tooth-desensitizing
VELLA 5% Sodium Fluoride Varnish Melon Case 12 Boxes 100 by Preventech — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- Varnish, Bulk, Oral-B, Bubblegum 1800 — YOUNG DENTAL MANUFACTURING I, LLC · Class II
- VOCO Profluorid Varnish — VOCO GmbH · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- IRIS — BENCO DENTAL SUPPLY CO. · Class II
- Pulp Canal Sealer — KERR ITALIA SRL · Class IIa
- MICROPRIME — DANVILLE MATERIALS, LLC · Class II
- VOCO Profluorid Varnish — VOCO GmbH · Class II
Cleared under the same submission
K140350 also covers:
- VELLA 5% Sodium Fluoride Varnish Bubble Gum Box 100 — Preventech
- VELLA 5% Sodium Fluoride Varnish Bubble Gum Box 35 — Preventech
- VELLA 5% Sodium Fluoride Varnish Bubble Gum Case 12 Boxes 100 — Preventech
- VELLA 5% Sodium Fluoride Varnish Caramel Box 100 — Preventech
- VELLA 5% Sodium Fluoride Varnish Caramel Box 35 — Preventech
- VELLA 5% Sodium Fluoride Varnish Caramel Case 12 Boxes 100 — Preventech
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 — Preventech
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Bubble Gum — Preventech
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Caramel — Preventech
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Melon — Preventech
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Strawberry — Preventech
- VELLA 5% Sodium Fluoride Varnish Melon Box 100 — Preventech
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
- Preventech
Sources (1)
- FDA UDI 27560727-8c35-4527-85d7-11370a6b43b1 36 fields · synced Jun 8, 2026