510(k) · Cleared
ClearedUninhibited
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 Aug 1, 2002 after an 84-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Aug 1, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- EBD
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK021503 UninhibitedBisco, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK073243 Led Pro SealReliance Orthodontic Products, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K073243Led Pro SealReliance Orthodontic Products, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021503 | Uninhibited | Bisco, Inc. | 2002 | — |
| +1 | K073243 | Led Pro Seal | Reliance Orthodontic Products, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | — | Fortify Named without a submission number |
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 |
|---|---|---|---|
| K073243 | Led Pro Seal | 2008 | 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, K073243 (Reliance Orthodontic Products, Inc., 2008) 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?
TO SEAL THE SURFACE OF:
DIRECT COMPOSITE RESTORATIONS
INDIRECT COMPOSITE RESTORATIONS
AMALGAM RESTORATIONS
WTRACORONAL SPLIENTS
EXTRACQRQNAL SPLINTS
LINGUAL. RETAINERS
ENAMEL SURFACES AROUND ORTHODONTIC BRACKETS
PROVISIONAL RESTORATIONS
PROCESSED ACRYLIC PRQSTHESES-REMOVABLE PARTIAL & CQMPLETE DENTUmS
AND MAXILLOFACIAL PROSTHESES
PKBCESSED ACRYLIC APPLIANCES-ORTHODONTIC EPETAI[NEWS
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021503 · printed Nov 3, 2026
Cite this page
510(k) Report. “K021503: Uninhibited.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021503
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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