510(k) · Cleared
ClearedPulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corp. · LBH Varnish, Cavity
Cleared on Mar 19, 1998 after a 129-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 19, 1998
- Review
- 129 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK974202 Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser PlusPulpdent Corp. · 1998
- Descendant · cites it directly · 4 of its ownK033938 Clearfil Protect BondKuraray Medical, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK210504 PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK191524 Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019
- Descendant · 2 generations on · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
Most influential descendants
Showing 5 of 5 · See all- K033938Clearfil Protect BondKuraray Medical, Inc. · 2004 · cites it directly4descendants
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on2descendants
- K210504PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021 · 3 generations on0descendants
- K191524Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019 · 3 generations on0descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974202 | Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus | Pulpdent Corp. | 1998 | — |
| +1 | K033938 | Clearfil Protect Bond | Kuraray Medical, Inc. | 2004 | — |
| +2 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +3 | K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021 | — |
| +3 | K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019 | — |
| +2 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LBH device
- #1 K262243 Profisil Freescore 12.8 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ultradent UltraCid Named without a submission number | |
| * | — | Ultradent UltraCid F Named without a submission number | |
| * | — | Ultradent Concepsis Named without a submission number | |
| * | — | Dental Therapeutics AB Tubulicid Plus Named without a submission number | |
| * | — | Dental Therapeutics AB Tubulicid Blue Label Named without a submission number | |
| * | — | Dental Therapeutics AB Tubulicid Red Label Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033938 | Clearfil Protect Bond | 2004 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K033938 (Kuraray Medical, Inc., 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LBH devicesLBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LBH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LBH
223in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LBH
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LBH
7in 2025
MAUDE reports naming product code LBH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 69 | 0 | 4 |
| 2008 | 6 | 79 | 0 | 3 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 7 | 107 | 0 | 7 |
| 2011 | 3 | 72 | 0 | 8 |
| 2012 | 4 | 83 | 0 | 7 |
| 2013 | 6 | 160 | 0 | 27 |
| 2014 | 6 | 204 | 3 | 40 |
| 2015 | 2 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 2 | 13 |
| 2019 | 2 | — | 1 | 9 |
| 2020 | 5 | 256 | 0 | 10 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 7 |
| 2023 | 3 | 167 | 0 | 8 |
| 2024 | 3 | 237 | 0 | 6 |
| 2025 | 4 | 223 | 0 | 7 |
| 2026 | 5 | 64 | 0 | — |
What is it indicated for?
Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity
preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp
tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and
composite resins. Recent studies have suggested that this cleansing step reduces
microleakage sensitivity in teeth undergoing treatment or restoration.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974202 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974202: Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974202
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026