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 Sep 18, 2008 as substantially equivalent to K992326 (3M Company, 1999) and 3 other predicates after a 113-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Sep 18, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K891536 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK891536 Enamel Microabrasion CompoundPremier Dental Products Co. · 1989
- This deviceK081493 Infiltration KitDmg USA, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891536 | Enamel Microabrasion Compound | Premier Dental Products Co. | 1989 | — |
| 0 (this device) | K081493 | Infiltration Kit | Dmg USA, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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? (4)
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 SealantSummary page 1…nt to several currently marketed dental restorative materials including the following: Infiltrant: 3M Clinpro Sealant K992326 (3M Company USA) Admira Seal K021842 (VOCO, GmbH) Grandio Seal… | 1999 |
| * | K021842 | Admira SealSummary page 1…llowing: Infiltrant: 3M Clinpro Sealant K992326 (3M Company USA) Admira Seal K021842 (VOCO, GmbH) Grandio Seal K062344 (VOCO, GmbH) HCI-Etching-Gel: [E… | 2002 |
| * | K062344 | Grandio SealSummary page 1…K992326 (3M Company USA) Admira Seal K021842 (VOCO, GmbH) Grandio Seal K062344 (VOCO, GmbH) HCI-Etching-Gel: [Enamel Microabrasion Compound K891536 (Premier Dental Products… | 2006 |
| * | K891536 | Enamel Microabrasion CompoundSummary page 1…, GmbH) Grandio Seal K062344 (VOCO, GmbH) HCI-Etching-Gel: [Enamel Microabrasion Compound K891536 (Premier Dental Products USA, Co.) I Safety and Performance: This submission is an Abbreviated 510(k) as described i… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 4 ancestors has a recall.
- 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. 2008, 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
The HCI Etching Gel is indicated for etching of enamel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081493: Infiltration Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081493
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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