510(k) · Cleared

Cleared

Spee-Dee Patch

K113617510(k) TraditionalCleared Mar 2, 201286-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

Pulpdent Corporation · EBF Material, Tooth Shade, Resin

Cleared on Mar 2, 2012 as substantially equivalent to K071278 (Pulpdent Corporation, 2007) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1988.

Decided: Mar 2, 2012
Review: 86 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K882006 (1988). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK882006 Clearfil Photo CoreKuraray Co. · 1988
This deviceK113617 Spee-Dee PatchPulpdent Corporation · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882006	Clearfil Photo Core	Kuraray Co.	1988	—
0 (this device)	K113617	Spee-Dee Patch	Pulpdent Corporation	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2007	1	0

FIG. 1 — Lineage of K113617, 1988–2012Source: 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? (3)

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
*	K071278	Embrace Dual Cure Composite Materials Summary page 1 …d-up and repair material. Embrace Monomer Mix Build-Up Material material that contains no Photo-initiator K 071278 Bisphenot A. Chemical initiator…	Pulpdent Corporation	2007	—
*	K020287	Dentition Integrating Material Summary page 1 …the pits and fissures in Embrace Monomer Mix Pit &Fissure Sealant resin-based material that teeth. Photo-initiator K020287 contains no Bisphenot A. Filler: Barium glass and submicron s…	Pulpdent Corporation	2002	—
*	K882006	Clearfil Photo Core Summary page 1 …Build-up and repair material Monomer Mix Photo Core composite. Photo-initiator K882006 Filler…	Kuraray Co.	1988	—

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?

None of the 3 ancestors has a recall.

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. 2012, 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?

Spee-Dee Patch is a visible light cured, glass-filled resin that is intended as a vital tooth build-up material where restorations were removed and must be built up for crown preparation; as a non-vital tooth post and core; as a build up material; and as a repair material to repair fractured cusps, lost partial or whole fillings, chipped crowns, broken teeth, crowns, or bridges.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113617 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113617: Spee-Dee Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113617

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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