510(k) · Cleared

Cleared

Biscover Led

K051999510(k) TraditionalCleared Aug 22, 200528-day reviewClass II21 CFR 872.3310

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bisco, Inc. · EBD Coating, Filling Material, Resin

Cleared on Aug 22, 2005 as substantially equivalent to K043168 (Bisco, Inc., 2005) after a 28-day review. Its family tree reaches back 2 generations to 2003.

Decided: Aug 22, 2005
Review: 28 days
Class: Class II
Product code: EBD
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K030354 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK030354 Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover…Bisco, Inc. · 2003
1 generation backK043168 Biscover LVBisco, Inc. · 2005
This deviceK051999 Biscover LedBisco, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K030354	Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity…	Bisco, Inc.	2003	—
−1	K043168	Biscover LV	Bisco, Inc.	2005	—
0 (this device)	K051999	Biscover Led	Bisco, Inc.	2005	—

FIG. 1 — Lineage of K051999, 2003–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K043168	Biscover LV Summary page 1 …rovisionals, acrylic appliances, Resin-Modified Glass lonomers, Enamel before or after orthodontic bracket placement, and etched Enamel. Predicate Devices: BISCOVER LV (K043 168) dated February 1, 2005. Significant Performance Characteristics: DISCOVER LED to DISCOVER LV…	Bisco, Inc.	2005	—

Also cleared against K043168: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
None of the 2 ancestors has a recall.
2 other devices also cite its predicate K043168.

How does its category compare?

All EBD devices

EBD Coating, Filling Material, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EBD

1in 2025

2007high 3 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBD

76in 2008

2007high 76 (2008)2026

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

2007high 5 (2023) · low 0 (2007)2025

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	MAUDE reports
2007	1	—	0
2008	3	76	2
2009	1	—	2
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	1	—	0
2014	1	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	1
2018	1	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	1
2022	0	—	0
2023	1	—	5
2024	1	—	0
2025	1	—	0
2026	1	—	—

What is it indicated for?

BISCOVER LED is a low-viscosity, light-cured resin formulation used to seal restorations and enamel while leaving a smooth polished surface.

BISCOVER LED is used to Seal and Polish:

1. Direct composites (cured)

2. Indirect composites

3. Provisionals

4. Acrylic appliances

5. Resin-modified Glass Ionomers

6. Enamel before or after orthodontic bracket placement

7. Etched Enamel

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051999 · printed Nov 4, 2026

Cite this page

510(k) Report. “K051999: Biscover Led.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051999

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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