510(k) · Cleared

Cleared

Dyract AP Restorative

K973235510(k) TraditionalCleared Feb 5, 1998161-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

Dentsply Intl. · EBF Material, Tooth Shade, Resin

Cleared on Feb 5, 1998 as substantially equivalent to K950991 (Dentsply Intl., 1995) after a 161-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.

Decided: Feb 5, 1998
Review: 161 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K950991 (1995). 10 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK950991 Dyract II RestorativeDentsply Intl. · 1995
This deviceK973235 Dyract AP RestorativeDentsply Intl. · 1998
Descendant · cites it directly · 3 of its ownK982395 Dytract Flow RestorativeDentsply Intl. · 1998
Descendant · cites it directly · 2 of its ownK040144 Quixx Posterior RestorativeDentsply International · 2004
Descendant · cites it directly · 1 of its ownK994056 AdmiraVoco GmbH · 2000
Descendant · 2 generations on · 0 of its ownK053391 X-Tra FilVoco GmbH · 2006
Descendant · cites it directly · 0 of its ownK050880 Dyract Extra RestorativeDentsply Intl. · 2005

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1998high 3 (1999) · low 0 (2002)2026

Most influential descendants

Showing 5 of 10 · See all

K982395Dytract Flow RestorativeDentsply Intl. · 1998 · cites it directly3descendants
K040144Quixx Posterior RestorativeDentsply International · 2004 · cites it directly2descendants
K994056AdmiraVoco GmbH · 2000 · cites it directly1descendant
K053391X-Tra FilVoco GmbH · 2006 · 2 generations on0descendants
K050880Dyract Extra RestorativeDentsply Intl. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950991	Dyract II Restorative	Dentsply Intl.	1995	—
0 (this device)	K973235	Dyract AP Restorative	Dentsply Intl.	1998	—
+1	K982395	Dytract Flow Restorative	Dentsply Intl.	1998	—
+1	K040144	Quixx Posterior Restorative	Dentsply International	2004	—
+1	K994056	Admira	Voco GmbH	2000	—
+2	K053391	X-Tra Fil	Voco GmbH	2006	—
+1	K050880	Dyract Extra Restorative	Dentsply Intl.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	3	0
2000	1	0
2001	1	0
2004	2	0
2005	1	0
2006	1	0

FIG. 1 — Lineage of K973235, 1995–2006Source: 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
*	K950991	Dyract II Restorative Summary page 1 …ED: August 27, 1997 TRADE OR PROPRIETARY NAME: DYRACT® AP RESTORATIVE CLASSIFICATION NAME: Tooth resin shade material 872.3690 PREDICATE DEVICE: DYRACT® Il Restorative K950991 DEVICE DESCRIPTION: DYRACT® AP RESTORATIVE is a one-component, visible light curing, dental restorative material, delivered in C…	Dentsply Intl.	1995	—

Also cleared against K950991: 1 other device →

What descends from it? (10)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K982395	Dytract Flow Restorative	Dentsply Intl.	1998	3
K040144	Quixx Posterior Restorative	Dentsply International	2004	2
K994056	Admira	Voco GmbH	2000	1
K050880	Dyract Extra Restorative	Dentsply Intl.	2005	0
K992909	HYTAC	Espe Dental AG	1999	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?

Its one ancestor has no recall.
Of its descendants, K982395 (Dentsply Intl., 1998) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K950991.

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	—

What is it indicated for?

Used as a permanent restorative material in all cavity classes for both permanent and deciduous teeth; as a base material underneath amalgams, ceramics, cast metal restorations, and composites; as a laminate or open sandwich technique; for root caries lesions; and for core build-up

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973235 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973235: Dyract AP Restorative.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973235

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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