510(k) · Cleared
ClearedSeal & Protect Protective Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · LBH Varnish, Cavity
Cleared on Aug 19, 2002 as substantially equivalent to K992822 (Dentsply Intl., 1999) after a 77-day review. Its family tree reaches back 6 generations to 1993. 4 later devices descend from it.
- Decided
- Aug 19, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931812 (1993). 9 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 2 generations backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- 1 generation backK992822 Seal & Protect Protective Sealant for Exposed DentineDentsply Intl. · 1999
- This deviceK021805 Seal & Protect Protective SealantDentsply Intl. · 2002
- Descendant · cites it directly · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
- Descendant · 2 generations on · 0 of its ownK070956 SEA2 Self Etch Adhesive3M Espe Dental Products · 2007
Most influential descendants
Showing 4 of 4 · See all- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · cites it directly3descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · 2 generations on0descendants
- K122522Dentoetch Quickbond Bond ActivatorItena Clinical · 2013 · 2 generations on0descendants
- K070956SEA2 Self Etch Adhesive3M Espe Dental Products · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −5 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −2 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| −1 | K992822 | Seal & Protect Protective Sealant for Exposed Dentine | Dentsply Intl. | 1999 | — |
| 0 (this device) | K021805 | Seal & Protect Protective Sealant | Dentsply Intl. | 2002 | — |
| +1 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +2 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
| +2 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
| +2 | K070956 | SEA2 Self Etch Adhesive | 3M Espe Dental Products | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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 12.9 · 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? (1)
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 |
|---|---|---|---|
| * | K992822 | Seal & Protect Protective Sealant for Exposed DentineSummary page 1…cavity varnish 872.3260 PREDICATE DEVICES: Seal & ProtectTMProtective Varnish K992822 DEVICE DESCRIPTION: Seal & ProtectTMProtective Varnish is a nanofilled light-curing dental varnish designed to protect exposed… | 1999 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023842 | Clearfil SE Bond Plus | 2003 | 3 |
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?
- The line of descent spans 9 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K023842 (Kuraray Medical, Inc., 2003) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K992822.
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?
Seal & Protect Protective Sealant is a protective sealant for exposed dentine. The indications for use are:
Reduction of abrasion and erosion of exposed cervical dentine
Treatment of hypersensitive cervical areas
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021805: Seal & Protect Protective Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021805
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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