510(k) K233768
- Device
- Papacarie Duo
- Applicant
- Elevate Oral Care
- 510(k) number
- K233768
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-18
- Date received
- 2023-11-24
- 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
- No
Related Records
Applicant Contact
- Contact
- Steven Pardue
- Address
- 346 Pike Rd. Suite 5 West Palm Beach FL US 33411 33411
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 |
| 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 |