510(k) · Cleared
ClearedSeal & Protect Protective Sealant for Exposed Dentine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · LBH Varnish, Cavity
Cleared on Nov 17, 1999 as substantially equivalent to K982394 (Dentsply Intl., 1998) after an 86-day review. Its family tree reaches back 5 generations to 1993. 9 later devices descend from it.
- Decided
- Nov 17, 1999
- Review
- 86 days
- Class
- Class II
- Product code
- LBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K931812 (1993). 8 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 4 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 3 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 2 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 1 generation backK982394 Prime & Bond NT Dual Cure Universal Dental Adhesive SystemDentsply Intl. · 1998
- This deviceK992822 Seal & Protect Protective Sealant for Exposed DentineDentsply Intl. · 1999
- Descendant · cites it directly · 4 of its ownK021805 Seal & Protect Protective SealantDentsply Intl. · 2002
- Descendant · 2 generations on · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · cites it directly · 3 of its ownK003482 Proclude-SensitiveOrtek Therapeutics, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK103461 Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011
- Descendant · 3 generations on · 1 of its ownK140481 Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief…Colgate-Palmolive Company · 2014
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K021805Seal & Protect Protective SealantDentsply Intl. · 2002 · cites it directly4descendants
- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · 2 generations on3descendants
- K003482Proclude-SensitiveOrtek Therapeutics, Inc. · 2001 · cites it directly3descendants
- K103461Colgate Desensitizing Dental CreamColgate-Palmolive Co. · 2011 · 2 generations on2descendants
- K140481Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashColgate-Palmolive Company · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −4 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −3 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −2 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −1 | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive System | Dentsply Intl. | 1998 | — |
| 0 (this device) | K992822 | Seal & Protect Protective Sealant for Exposed Dentine | Dentsply Intl. | 1999 | — |
| +1 | K021805 | Seal & Protect Protective Sealant | Dentsply Intl. | 2002 | — |
| +2 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +1 | K003482 | Proclude-Sensitive | Ortek Therapeutics, Inc. | 2001 | — |
| +2 | K103461 | Colgate Desensitizing Dental Cream | Colgate-Palmolive Co. | 2011 | — |
| +3 | K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief Mouthwash | Colgate-Palmolive Company | 2014 | — |
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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K982394 | Prime & Bond NT Dual Cure Universal Dental Adhesive SystemSummary page 1…: TRADE OR PROPRIETARY NAME: SEAL & PROTECT™ DENTAL VARNISH CLASSIFICATION NAME: cavity varnish 872.3280 PREDICATE DEVICES: Prime & Bond® NT™ Universal Dental Adhesive K982394 DEVICE DESCRIPTION: SEAL & PROTECT™ DENTAL VARNISH is a nanofilled light-curing dental varnish designed to protect exposed denti… | 1998 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K021805 (Dentsply Intl., 2002) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K982394.
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™ DENTAL VARNISH 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992822: Seal & Protect Protective Sealant for Exposed Dentine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992822
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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