510(k) · Cleared
ClearedSculpting Resin
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 Apr 28, 2003 after a 63-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Apr 28, 2003
- Review
- 63 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK030585 Sculpting ResinBisco, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK092730 Cosmedent Brushable CompositeCosmedent, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK092539 SeamfreeApex Dental Materials, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK042804 Tescera Opaquer Powder/Sculpting ResinBisco, 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 |
|---|---|---|---|---|---|
| 0 (this device) | K030585 | Sculpting Resin | Bisco, Inc. | 2003 | — |
| +1 | K092730 | Cosmedent Brushable Composite | Cosmedent, Inc. | 2009 | — |
| +1 | K092539 | Seamfree | Apex Dental Materials, Inc. | 2009 | — |
| +1 | K042804 | Tescera Opaquer Powder/Sculpting Resin | Bisco, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | — | Ultradent Composite Wetting Resin Named without a submission number |
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?
- Of its descendants, K092730 (Cosmedent, Inc., 2009) has gone furthest, with 0 descendants of its own.
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?
The intended use of Bisco's Sculpting Resin is as a pre-wetting agent for placing and sculpting layers of composites and between layers of cured composite
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030585: Sculpting Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030585
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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