510(k) K220419
- Device
- Apapro Desensitizer
- Applicant
- Sangi Co, Ltd
- 510(k) number
- K220419
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-02-16
- Date received
- 2022-02-14
- Regulation
- 872.3260
- Classification name
- Varnish, Cavity
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- Douglas Mercadante
- Address
- 3-11-6 Tsukiji, Chuo-Ku Tokyo JP 104-8440 104-8440
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 |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | 2020-11-06 |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020-06-25 |
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor | Scientific Pharmaceuticals | 2020-02-18 |
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