510(k) · Cleared

Cleared

REVEAL Bulk

K171147510(k) TraditionalCleared Aug 4, 2017107-day reviewClass II21 CFR 872.3690

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

Bisco, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Aug 4, 2017 as substantially equivalent to K141081 (3M Espe Dental Products, 2014) after a 107-day review. Its family tree reaches back 2 generations to 2008.

Decided: Aug 4, 2017
Review: 107 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K083610 (2008). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK083610 Filtek Supreme Ultra Universal Restorative3M Company · 2008
1 generation backK141081 Filtek Bulk Fill Posterior Restroative3M Espe Dental Products · 2014
This deviceK171147 REVEAL BulkBisco, Inc. · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K083610	Filtek Supreme Ultra Universal Restorative	3M Company	2008	—
−1	K141081	Filtek Bulk Fill Posterior Restroative	3M Espe Dental Products	2014	—
0 (this device)	K171147	REVEAL Bulk	Bisco, Inc.	2017	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0

FIG. 1 — Lineage of K171147, 2008–2017Source: 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 EBF? 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 EBF device

#1 K202846 Tera Harzscore 18.5 · 7 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
*	K141081	Filtek Bulk Fill Posterior Restroative Summary page 4 …Class II per 21 CFR 872.3690 Predicate Devices: REVEAL Bulk is substantially equivalent to: Filtek Bulk Fill Posterior Restorative, by 3M ESPE, K141081 Indications for Use: 1) Direct anterior and posterior restorations (including occlusal surfaces) 2) Base/liner under direct res…	3M Espe Dental Products	2014	—

Also cleared against K141081: 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 9 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K141081.

How does its category compare?

All EBF devices

EBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · EBF

15in 2025

2007high 20 (2009) · low 9 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBF

43in 2025

2007high 205 (2016) · low 43 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EBF

1in 2020

2007high 42 (2008) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBF

1in 2025

2007high 246 (2013) · low 1 (2025)2025

MAUDE reports naming product code EBF, 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	19	49	1	6
2008	14	79	42	10
2009	20	84	1	8
2010	19	75	6	31
2011	19	81	7	31
2012	11	86	0	62
2013	13	153	0	246
2014	10	112	0	195
2015	17	123	0	119
2016	20	205	0	143
2017	15	108	4	42
2018	15	115	0	8
2019	17	159	2	11
2020	15	190	1	2
2021	13	178	0	2
2022	17	63	0	2
2023	9	87	0	8
2024	18	120	0	5
2025	15	43	0	1
2026	16	59	2	—

What is it indicated for?

1) Direct anterior and posterior restorations (including occlusal surfaces)

2) Base/liner under direct restorations

3) Core build-ups

4) Splinting

5) Indirect restorations including inlays, onlays and veneers

6) Restorations of deciduous teeth

7) Extended fissure sealing in molars and premolars

8) Repair of defects in porcelain restorations, enamel, and temporaries

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171147 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171147: REVEAL Bulk.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171147

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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