510(k) · Cleared
ClearedSPK Sealant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Sep 3, 2009 as substantially equivalent to K992326 (3M Company, 1999) and 4 other predicates after a 91-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 3, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K011200 (2001). 8 ancestors in all, the oldest K992326 (1999). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011200 Gilb, Model 80103M Company · 2001
- 1 generation backK073395 Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008
- This deviceK091632 SPK Sealant3M Company · 2009
- Descendant · cites it directly · 1 of its ownK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011200 | Gilb, Model 8010 | 3M Company | 2001 | — |
| −1 | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| 0 (this device) | K091632 | SPK Sealant | 3M Company | 2009 | — |
| +1 | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +2 | K251124 | G-Bond Universal | GC America, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2006 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2025 | 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 EBC? 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 EBC device
- #1 K243254 Parkell Pit and Fissure Sealantscore 12.8 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K992326 | 3M Clinpro Sealant Our OCR of the scanned summary read K092326, FDA’s number for Smoothcool (Jeisys Medical, Inc.), decided Mar 5, 2010, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Clinpro Sealant”. | 1999 |
| * | K011491 | Helioseal Clear Chroma | 2001 |
| * | K062344 | Grandio SealSummary page 1…EBC Predicate Devices 510(k) DeviceName 10992326 ClinproScalant, 3M ESPE.DontallProducts K0.11491 Heliodeal: Clear' Chroma,,[voclar;NA, Inc. K062344 Grandlo Seal; VOCO GOibi K061997 Enamel Loc S6alant. :Premier: Dental Produc's Company K073395 Glass lonom… | 2006 |
| * | K061997 | Premier Self-Etching Enamel SealantSummary page 1…DeviceName 10992326 ClinproScalant, 3M ESPE.DontallProducts K0.11491 Heliodeal: Clear' Chroma,,[voclar;NA, Inc. K062344 Grandlo Seal; VOCO GOibi K061997 Enamel Loc S6alant. :Premier: Dental Produc's Company K073395 Glass lonomer Protective Coating, 3M ESPE Dental Pro… | 2006 |
| * | K073395 | Gilb-2, Glass Ionomer Protective CoatingSummary page 1…K0.11491 Heliodeal: Clear' Chroma,,[voclar;NA, Inc. K062344 Grandlo Seal; VOCO GOibi K061997 Enamel Loc S6alant. :Premier: Dental Produc's Company K073395 Glass lonomer Protective Coating, 3M ESPE Dental Products Description and Technology Equivalence: SPK Sealant is moistur… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100062 | Infiltration Kit | 2010 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K100062 (Dmg USA, Inc., 2010) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K992326.
How does its category compare?
All EBC devicesEBC Sealant, Pit And Fissure, And Conditioner: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBC
80in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBC
2in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBC
6in 2025
MAUDE reports naming product code EBC, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 5 | 115 | 0 | 0 |
| 2011 | 3 | 80 | 0 | 5 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 11 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 2 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 6 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Sealing pits-and-fissures, damaged-enamel surfaces and exposed dentin surfaces of teeth to prevent caries
Protective coating for tooth surfaces predisposed to caries or non-cavitated lesions (e.g. including use in tooth brush-abrasion and root surfaces)
Covering of caries predilection sites during orthodontic treatment
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/K091632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091632: SPK Sealant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091632
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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