510(k) K140350
- Device
- VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
- Applicant
- PREVENTIVE TECHNOLOGIES, INC.
- 510(k) number
- K140350
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-12-12
- Date received
- 2014-02-11
- Regulation
- 872.3260
- Classification name
- Varnish, Cavity
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KENNETH S PETERSON
- Address
- 4330c Matthews Indian Trl. Rd. Indian Trail NC US 28079 28079
FDA Registration Numbers#
- 1410097
- 3013584861
- 9612352
- 1281412
- 1420052
- 1218077
- 1061053
- 1833025
- 3031841433
- 9681356
- 2086043
- 2218158
- 3012187973
- 9680945
- 3005665377
- 3004475754
- 9613953
- 3003449480
- 3002807050
- 1215305
- 9611959
- 3010131268
- 3026630
- 3004967419
- 1319130
- 8010908
- 2511556
- 3011632
- 2424472
- 3003621174
- 3038718579
- 9615332
- 3026400121
- 2242327
- 3007113445
- 1000272892
- 3010864832
- 3012117640
- 2244812
- 3010002722
- 1721647
- 3005686375
- 3006444232
- 2515379
- 3043226252
- 3009603151
- 9612300
- 1723973
- 1413475
- 2429849
- 2214133
- 3002808149
- 2183301
- 3042272797
- 2133714
- 3027584973
- 3012494290
- 1718912
- 3000219976
- 2513595
- 3002807420
- 3014615644
- 1941138
- 3009496224
- 2244842
- 3012118920
- 9611385
- 2022039
- 3011430871
- 3028011
- 9610902
- 3032163716
- 3025666291
- 3006805063
- 2018957
- 3003896222
- 1013257
- 3004966444
- 2437780
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LBH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | 2026-05-01 |
| K261404 | UltraEZ | Ultradent Products, Inc. | 2026-04-30 |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | 2026-03-18 |
| K250714 | FluoroDose Varnish | Centrix, Inc. | 2025-11-21 |
| K243777 | Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) | Theodent, LLC | 2025-05-27 |
| K241489 | ReminGel | Inter-Med, Inc. | 2025-01-08 |
| K241568 | CrystLCare™ PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | 2025-01-02 |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | 2024-11-22 |
| K233768 | Papacarie Duo | Elevate Oral Care | 2024-07-18 |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | 2024-06-13 |
| K230333 | 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) | Kettenbach GmbH & Co. KG | 2023-07-24 |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | 2023-05-25 |
| K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | 2023-05-10 |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022-02-16 |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | 2020-11-06 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases