510(k) · Cleared
ClearedInfiltration Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dmg USA, Inc. · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Mar 26, 2010 as substantially equivalent to K091632 (3M Company, 2009) after a 74-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Mar 26, 2010
- Review
- 74 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011200 (2001). 9 ancestors in all, the oldest K992326 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK011200 Gilb, Model 80103M Company · 2001
- 2 generations backK073395 Gilb-2, Glass Ionomer Protective Coating3M Espe Dental Products · 2008
- 1 generation backK091632 SPK Sealant3M Company · 2009
- This deviceK100062 Infiltration KitDmg USA, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK251124 G-Bond UniversalGC America, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251124G-Bond UniversalGC America, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011200 | Gilb, Model 8010 | 3M Company | 2001 | — |
| −2 | K073395 | Gilb-2, Glass Ionomer Protective Coating | 3M Espe Dental Products | 2008 | — |
| −1 | K091632 | SPK Sealant | 3M Company | 2009 | — |
| 0 (this device) | K100062 | Infiltration Kit | Dmg USA, Inc. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081439 | FDA’s K081439 is Vitoss Bioactive Foam Pack Bone Graft Substitute Our reading of the summary gave K081439, FDA’s number for Vitoss Bioactive Foam Pack Bone Graft Substitute (Orthovita, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Infiltration Kit”. Kept off the family tree. Summary page 1…ssion is 'identical to that cleared in K08 1493. This submission is for a labeling change to expand the indications for use statement for the Infiltration Kit cleared in K081439 to include two specific uses for the material: Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent… | 2008 |
| * | K091632 | SPK SealantSummary page 1…onditioner (21 CFR 872.3765; Class II) Predicate Devices: Infiltration Kit; KOS 1439 (DM0 USA, Inc.) SPK Sealant; K091632 (3M ESPE) Product Description: The DM0 USA Infiltration Kit consists of two components, a light curing methacrylate resin-based… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251124 | G-Bond Universal | 2025 | 0 |
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 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K251124 (GC America, Inc., 2025) has gone furthest, with 0 descendants of its own.
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. 2010, 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?
The Sealant (Infiltrant) is indicated for:
- Sealing of pits and fissures
- Sealing/facing of damaged enamel surfaces
- Covering of caries predilection sites during orthodontic treatment
- Sealing of secondary teeth
- Sealing of deciduous teeth
- Sealing of damaged enamel surfaces and exposed dentin surfaces of teeth to prevent caries
- Protective coating for tooth surfaces predisposed to caries or on early non-cavitated lesions (including use in tooth brush abrasion and root surfaces)
HCI-Etching-Gel is indicated for:
- Etching of enamel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100062 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100062: Infiltration Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100062
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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