510(k) K231338
- Device
- 3M? Clinpro? Clear 2.1% Sodium Fluoride Treatment
- Applicant
- 3M Espe Dental Products
- 510(k) number
- K231338
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-10
- Date received
- 2023-05-08
- 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
Related Records
Applicant Contact
- Contact
- Chandrapaul Parsram
- Address
- 2510 Conway Ave. Saint Paul MN US 55144 55144
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
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 |
| 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 |