510(k) · Cleared
ClearedOrthosource Etch Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Source · EBC Sealant, Pit And Fissure, And Conditioner
Cleared on Apr 11, 1986 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Apr 11, 1986
- Review
- 9 days
- Class
- Class II
- Product code
- EBC
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK861245 Orthosource Etch SystemsOrtho Source · 1986
- Descendant · cites it directly · 0 of its ownK990306 Hydro-Cast Dental Etching Gel, Model 60025Kay See Dental Mfg. Co. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990306Hydro-Cast Dental Etching Gel, Model 60025Kay See Dental Mfg. Co. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K861245 | Orthosource Etch Systems | Ortho Source | 1986 | — |
| +1 | K990306 | Hydro-Cast Dental Etching Gel, Model 60025 | Kay See Dental Mfg. Co. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K990306 | Hydro-Cast Dental Etching Gel, Model 60025 | 1999 | 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?
- Of its descendants, K990306 (Kay See Dental Mfg. Co., 1999) 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.
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 | — |
https://510kreport.com/device/K861245 · printed Nov 5, 2026
Cite this page
510(k) Report. “K861245: Orthosource Etch Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K861245
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026