510(k) K013411
- Device
- PULPDENT CAVITY PREPARATION IV
- Applicant
- Pulpdent Corp.
- 510(k) number
- K013411
- Product code
- LBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-12
- Date received
- 2001-10-15
- 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
- KENNETH J BERK
- Address
- 80 Oakland St. P.O. Box 780 Watertown MA US 02471 02471
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
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|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | 2026-05-01 |
| K261404 | UltraEZ | Ultradent Products, Inc. | 2026-04-30 |
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| K250714 | FluoroDose Varnish | Centrix, Inc. | 2025-11-21 |
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| 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 |