510(k) K090519
- Device
- VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
- Applicant
- 3M COMPANY
- 510(k) number
- K090519
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-04-15
- Date received
- 2009-02-26
- Regulation
- 872.3260
- Classification name
- Varnish, Cavity
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN O'MALLEY
- Address
- 3m Center, Bldg. 260-2a-17 St Paul MN US 55144 55144
FDA Registration Numbers#
- 3038718579
- 9611385
- 2523320
- 2031532
- 1215305
- 2244842
- 3013584861
- 3021035729
- 1723973
- 2511556
- 3012996495
- 8010908
- 1051594
- 2429849
- 3002808149
- 1410097
- 2437780
- 3002807050
- 3004475754
- 2022039
- 3004967419
- 3014615644
- 9612300
- 3043226252
- 3010131268
- 3000219976
- 3012421607
- 3003621174
- 2424472
- 1000272892
- 2218158
- 3005665377
- 2086043
- 2513595
- 3010002722
- 3026400121
- 3003449480
- 1281412
- 3042272797
- 1718912
- 3027584973
- 3006444232
- 1721647
- 1833025
- 3011430871
- 3005686375
- 3003896222
- 9680945
- 2183301
- 3007113445
- 2133714
- 9612352
- 1941138
- 3031841433
- 3002807420
- 3004966444
- 1218077
- 1319130
- 1450653
- 3012117640
- 3009496224
- 1420052
- 3011632
- 2018957
- 3004140838
- 3012118920
- 3025666291
- 9613953
- 3012187973
- 9681356
- 1013257
- 9610902
- 3010864832
- 3006805063
- 3026630
- 2214133
- 1413475
- 3028011
- 3032163716
Source Documents#
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 |
| 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 |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020-06-25 |
Legacy Summary#
summary
FDA Review#
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