510(k) K243777
- Device
- Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)
- Applicant
- Theodent, LLC
- 510(k) number
- K243777
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-27
- Date received
- 2024-12-09
- 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
- N
Related Records
Applicant Contact
- Contact
- Joseph Fuselier
- Address
- 1441 Canal St. New Orleans LA US 70112 70112
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 |
| 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 |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020-06-25 |