510(k) · Cleared

Cleared

Hytac Aplitip/Hytac Osb

K962442510(k) TraditionalCleared Sep 11, 199679-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

Espe GmbH & Co. Kg. · EBF Material, Tooth Shade, Resin

Cleared on Sep 11, 1996 as substantially equivalent to K900510 (Espe GmbH (Us), 1990) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1990. 9 later devices descend from it.

Decided: Sep 11, 1996
Review: 79 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K900510 (1990). 3 ancestors in all. 9 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK900510 Pertac-HybridEspe GmbH (Us) · 1990
This deviceK962442 Hytac Aplitip/Hytac OsbEspe GmbH & Co. Kg. · 1996
Descendant · cites it directly · 5 of its ownK984246 Prompt L-PopEspe Dental AG · 1999
Descendant · cites it directly · 1 of its ownK992966 ReferenceEspe Dental AG · 1999
Descendant · 2 generations on · 0 of its ownK210945 Ultra SEPReliance Orthodontic Products, Inc. · 2021
Descendant · 2 generations on · 0 of its ownK071688 Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007
Descendant · 2 generations on · 0 of its ownK993566 PromptflowEspe Dental AG · 1999

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

1998high 5 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 9 · See all

K984246Prompt L-PopEspe Dental AG · 1999 · cites it directly5descendants
K992966ReferenceEspe Dental AG · 1999 · cites it directly1descendant
K210945Ultra SEPReliance Orthodontic Products, Inc. · 2021 · 2 generations on0descendants
K071688Reliance S.E.P.Reliance Orthodontic Products, Inc. · 2007 · 2 generations on0descendants
K993566PromptflowEspe Dental AG · 1999 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900510	Pertac-Hybrid	Espe GmbH (Us)	1990	—
0 (this device)	K962442	Hytac Aplitip/Hytac Osb	Espe GmbH & Co. Kg.	1996	—
+1	K984246	Prompt L-Pop	Espe Dental AG	1999	—
+1	K992966	Reference	Espe Dental AG	1999	—
+2	K210945	Ultra SEP	Reliance Orthodontic Products, Inc.	2021	—
+2	K071688	Reliance S.E.P.	Reliance Orthodontic Products, Inc.	2007	—
+2	K993566	Promptflow	Espe Dental AG	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	5	0
2007	1	0
2021	1	0

FIG. 1 — Lineage of K962442, 1990–2021Source: 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
*	K900510	Pertac-Hybrid Summary page 1 …EFFECTIVENESS ESPE is submitting a 510(k) premarket notification for modifications to its 510(k) submissions for tooth shade resin material, tradenamed Pertac®-Hybrid® (K900510), and the corresponding bonding agent, tradenamed Pertac® Universal Bond (K904289) . The modified materials, referred to by the t…	Espe GmbH (Us)	1990	—
*	K951836	Compolglass Compoglass Sca Summary page 1 …illing materials. With respect to Hytac® Aplitip®, ESPE is claiming substantial equivalence to its previously cleared Pertac®-Hybrid® product and Ivoclar's Compoglass® (K951836). These products have similar intended uses and, in the case of Compoglass®, the same principal ingredient composition. To suppor…	Ivoclar North America, Inc.	1995	—
*	K904289	Pertac Universal Bond Summary page 1 …s to its 510(k) submissions for tooth shade resin material, tradenamed Pertac®-Hybrid® (K900510), and the corresponding bonding agent, tradenamed Pertac® Universal Bond (K904289) . The modified materials, referred to by the tradenames Hytac® Aplitip® and Hytac® 0SB, respectively, are intended as compomer f…	Espe GmbH (Us)	1990	—

Also cleared against K900510: 1 other device →

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K984246	Prompt L-Pop	Espe Dental AG	1999	5
K992966	Reference	Espe Dental AG	1999	1
K992909	HYTAC	Espe Dental AG	1999	0
K983414	Everbond	Espe Dental AG	1998	0
K982692	Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC	Sterngold/Implamed	1998	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?

None of the 3 ancestors has a recall.
Of its descendants, K984246 (Espe Dental AG, 1999) has gone furthest, with 5 descendants of its own.
1 other device also cites its predicate K900510.

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?

Hytac® Aplitip® is a compomer filling material indicated for the following uses: (1) fillings in deciduous teeth; (2) fillings in Class V cavities; (3) eroded and abraded cervical areas; (4) fillings in Class III cavities; and (5) temporary fillings in Class I and II cavities. Hytac® OSB is a light cured bonding agent for use with compomer filling materials.

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/K962442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962442: Hytac Aplitip/Hytac Osb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962442

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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