510(k) · Cleared
ClearedBiscover LV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EBD Coating, Filling Material, Resin
Cleared on Feb 1, 2005 as substantially equivalent to K030354 (Bisco, Inc., 2003) after a 77-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- Feb 1, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K030354 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK030354 Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover…Bisco, Inc. · 2003
- This deviceK043168 Biscover LVBisco, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK070306 Paint- on Polish AgentDentsply International, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK063228 Surface CoatKuraray America, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK051999 Biscover LedBisco, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K030354 | Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity… | Bisco, Inc. | 2003 | — |
| 0 (this device) | K043168 | Biscover LV | Bisco, Inc. | 2005 | — |
| +1 | K070306 | Paint- on Polish Agent | Dentsply International, Inc. | 2007 | — |
| +1 | K063228 | Surface Coat | Kuraray America, Inc. | 2006 | — |
| +1 | K051999 | Biscover Led | Bisco, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 EBD? 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 EBD device
- #1 K254091 Glossy Coat (15ML)score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K030354 | Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity ModifierSummary page 1…s, acryli appliances, Resin-Modified Glass lonomers, Enamel before or after orthodontic bracket placement, and etched Enamel. Predicate Devices: BISCOVER Liquid Polish (K030354) dated February 19, 2003. Significant Performance Characteristics: BISCOVER LV to BISCOVER Liquid… | 2003 |
What descends from it? (3)
3 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?
How does its category compare?
All EBD devicesEBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBD
76in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBD
No recall names EBD since 2007.
Adverse event reports per year · EBD
5in 2023
MAUDE reports naming product code EBD, 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 | 0 |
| 2008 | 3 | 76 | 0 | 2 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
BISCOVER LV is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.
BISCOVER LV is used to Seal and Polish:
1. Direct composites (cured)
2. Indirect composites
3. Provisionals
4. Acrylic appliances
5. Resin-modified Glass lonomers
6. Enamel before or after orthodontic bracket placement
7. Etched Enamel
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043168: Biscover LV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043168
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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