510(k) · Cleared

Cleared

Foundation Indirect Composite Resin

K970495510(k) TraditionalCleared Apr 16, 199765-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

Sybron Dental Specialties, Inc. · EBF Material, Tooth Shade, Resin

Cleared on Apr 16, 1997 as substantially equivalent to K955331 (Sybron Dental Specialties, Inc., 1996) after a 65-day review. Its family tree reaches back 1 generation to 1996.

Decided: Apr 16, 1997
Review: 65 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K955331 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK955331 BelleglashpSybron Dental Specialties, Inc. · 1996
This deviceK970495 Foundation Indirect Composite ResinSybron Dental Specialties, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955331	Belleglashp	Sybron Dental Specialties, Inc.	1996	—
0 (this device)	K970495	Foundation Indirect Composite Resin	Sybron Dental Specialties, Inc.	1997	—

FIG. 1 — Lineage of K970495, 1996–1997Source: 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
*	K955331	Belleglashp Summary page 1 …t Glass ( Hereas Kulzer GmbH ) BACKGROUND Kerr introduced a new composire resin based Crown and Bridge fabrication system called belleGlass HP in May, 1996 ( Reference K955331 ). This system is comprised of all of the components necessary for a dental laboratory to fabricate composite resin-based Crowns…	Sybron Dental Specialties, Inc.	1996	—
*	—	Concept Named without a submission number			—
*	—	Art Glass Named without a submission number			—

Also cleared against K955331: 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?

Its one ancestor has no recall.
2 other devices also cite its predicate K955331.

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.

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	—

https://510kreport.com/device/K970495 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970495: Foundation Indirect Composite Resin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970495

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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