510(k) · Cleared
ClearedOrtho-Jet Acrylic Resin - Sparkle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lang Dental Mfg. Co., Inc. · EBI Resin, Denture, Relining, Repairing, Rebasing
Cleared on May 27, 1994 after a 37-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 27, 1994
- Review
- 37 days
- Class
- Class II
- Product code
- EBI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK941925 Ortho-Jet Acrylic Resin - SparkleLang Dental Mfg. Co., Inc. · 1994
- Descendant · cites it directly · 1 of its ownK141439 Orthodontic Acrylic (Not Finalized)Bisco, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK014144 Extoral/Tescera Glazing Resin, Model T-1804Afp Imaging Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK163482 Orthodontic Acrylic 2Lang Dental Manufacturing Co., Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK024046 Tescera Glazing Resin, Model T-1804, Biscover XT, Model G-93220PBisco, Inc. · 2003
Most influential descendants
Showing 4 of 4 · See all- K141439Orthodontic Acrylic (Not Finalized)Bisco, Inc. · 2014 · cites it directly1descendant
- K014144Extoral/Tescera Glazing Resin, Model T-1804Afp Imaging Corp. · 2002 · cites it directly1descendant
- K163482Orthodontic Acrylic 2Lang Dental Manufacturing Co., Inc. · 2017 · 2 generations on0descendants
- K024046Tescera Glazing Resin, Model T-1804, Biscover XT, Model G-93220PBisco, Inc. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K941925 | Ortho-Jet Acrylic Resin - Sparkle | Lang Dental Mfg. Co., Inc. | 1994 | — |
| +1 | K141439 | Orthodontic Acrylic (Not Finalized) | Bisco, Inc. | 2014 | — |
| +1 | K014144 | Extoral/Tescera Glazing Resin, Model T-1804 | Afp Imaging Corp. | 2002 | — |
| +2 | K163482 | Orthodontic Acrylic 2 | Lang Dental Manufacturing Co., Inc. | 2017 | — |
| +2 | K024046 | Tescera Glazing Resin, Model T-1804, Biscover XT, Model G-93220P | Bisco, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 EBI? 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 EBI device
- #1 K250617 Apex Flexscore 18.3 · 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K141439 (Bisco, Inc., 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EBI devicesEBI Resin, Denture, Relining, Repairing, Rebasing: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBI
79in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBI
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBI
34in 2025
MAUDE reports naming product code EBI, 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 | 10 | 53 | 0 | 7 |
| 2008 | 6 | 124 | 0 | 2 |
| 2009 | 3 | 234 | 0 | 5 |
| 2010 | 4 | 95 | 0 | 4 |
| 2011 | 11 | 113 | 0 | 6 |
| 2012 | 3 | 85 | 0 | 9 |
| 2013 | 5 | 135 | 0 | 5 |
| 2014 | 5 | 102 | 0 | 9 |
| 2015 | 9 | 106 | 0 | 8 |
| 2016 | 7 | 147 | 0 | 9 |
| 2017 | 8 | 196 | 0 | 2 |
| 2018 | 5 | 158 | 2 | 2 |
| 2019 | 4 | 127 | 0 | 10 |
| 2020 | 6 | 283 | 0 | 8 |
| 2021 | 4 | 99 | 0 | 25 |
| 2022 | 11 | 154 | 2 | 2 |
| 2023 | 11 | 96 | 0 | 13 |
| 2024 | 9 | 90 | 0 | 1 |
| 2025 | 11 | 79 | 0 | 34 |
| 2026 | 7 | 87 | 0 | — |
https://510kreport.com/device/K941925 · printed Nov 3, 2026
Cite this page
510(k) Report. “K941925: Ortho-Jet Acrylic Resin - Sparkle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K941925
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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