VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
FDA 510(k) clearance K140350 · decided 2014-12-12
Clearance details
- K-number
- K140350
- Device name
- VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
- Applicant
- Preventive Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-02-11
- Decision date
- 2014-12-12
- Days to decision
- 304 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Indian Trail, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Fluoride Varnish (Type A,Type C) (K253052) | Nagy Oral Technology Qinhuangdao Co., Ltd. | 2026-06-11 |
| VOCO Profluorid Varnish + BioMin (K252073) | Voco GmbH | 2026-05-01 |
| UltraEZ (K261404) | Ultradent Products, Inc. | 2026-04-30 |
| APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (K260830) | Sangi Co., Ltd. | 2026-03-18 |
| FluoroDose Varnish (K250714) | Centrix, Inc. | 2025-11-21 |
| Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (K243777) | Theodent, LLC | 2025-05-27 |
| ReminGel (K241489) | Inter-Med, Inc. | 2025-01-08 |
| CrystLCare™ PRO Biorestorative, Fluoride-Plus (K241568) | GreenMark Biomedical, Inc. | 2025-01-02 |
| Jasmate® Toothpaste (K242913) | Jasberry Healthcare Private Limited | 2024-11-22 |
| Papacarie Duo (K233768) | Elevate Oral Care | 2024-07-18 |
| ProMin Dental Desensitizing Gel (K231060) | Belport Company, Inc., Gingi-Pak | 2024-06-13 |
| Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) (K230333) | Kettenbach GmbH & Co. KG | 2023-07-24 |
Recalls involving this device
No recalls on record reference this clearance.