510(k) · Cleared

Cleared

Opallis, Opallis Flow

K201707510(k) TraditionalCleared Dec 22, 2020183-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

Dentscare Ltda · EBF Material, Tooth Shade, Resin

Cleared on Dec 22, 2020 as substantially equivalent to K042819 (Ivoclar Vivadent, Inc., 2004) and 1 other predicate after a 183-day review. Its family tree reaches back 1 generation to 1999. 2 later devices descend from it.

Decided: Dec 22, 2020
Review: 183 days
Class: Class II
Product code: EBF
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K993783 (1999). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK993783 Tetric FlowIvoclar North America, Inc. · 1999
This deviceK201707 Opallis, Opallis FlowDentscare Ltda · 2020
Descendant · cites it directly · 0 of its ownK232994 Vittra APS Unique FlowDentscare Ltda · 2024
Descendant · cites it directly · 0 of its ownK231263 Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited · 2024

Most influential descendants

Showing 2 of 2 · See all

K232994Vittra APS Unique FlowDentscare Ltda · 2024 · cites it directly0descendants
K231263Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTPrevest Denpro Limited · 2024 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993783	Tetric Flow	Ivoclar North America, Inc.	1999	—
0 (this device)	K201707	Opallis, Opallis Flow	Dentscare Ltda	2020	—
+1	K232994	Vittra APS Unique Flow	Dentscare Ltda	2024	—
+1	K231263	Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT	Prevest Denpro Limited	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	2	0

FIG. 1 — Lineage of K201707, 1999–2024Source: 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? (2)

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
*	K042819	Tetric Evoceram Summary page 4 …510(k) Model Company Number Primary Predicate K042819 TETRIC EVOCERAM IVOCLAR VIVADENT AG Secondary Predicate K993783 TETRIC EVOFLOW…	Ivoclar Vivadent, Inc.	2004	—
*	K993783	Tetric Flow Summary page 4 …ompany Number Primary Predicate K042819 TETRIC EVOCERAM IVOCLAR VIVADENT AG Secondary Predicate K993783 TETRIC EVOFLOW IVOCLAR VIVADENT AG…	Ivoclar North America, Inc.	1999	—
†	K191306	Llis, Vittra APS	Dentscare Ltda	2019	—
†	K192682	Orthocem, Ortho Bite	Dentscare Ltda	2020	—

Also cleared against K042819: 13 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K232994	Vittra APS Unique Flow	Dentscare Ltda	2024	0
K231263	Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT	Prevest Denpro Limited	2024	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 2 ancestors has a recall.
Of its descendants, K232994 (Dentscare Ltda, 2024) has gone furthest, with 0 descendants of its own.
13 other devices also cite its predicate K042819.

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. 2020, 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?

Opallis (Sculptable version) The composite is suitable for use in permanent and deciduous teeth: - Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI. - Direct veneers with composites. - Cementation of tooth fragments. - Core build-ups. - Teeth splinting. - Diastema closing or reduction. - Modification of teeth's shape (e.g.: conoid teeth). - Porcelain/composite repairs. Opallis Flow (Flowable version) - Base/lining…

Read the full statement (116 words)

Opallis (Sculptable version)

The composite is suitable for use in permanent and deciduous teeth:

- Direct restorations in anterior and posterior teeth Classes I, II, III, IV, V and VI.

- Direct veneers with composites.

- Cementation of tooth fragments.

- Core build-ups.

- Teeth splinting.

- Diastema closing or reduction.

- Modification of teeth's shape (e.g.: conoid teeth).

- Porcelain/composite repairs.

Opallis Flow (Flowable version)

- Base/lining underneath direct restorations.

- Small, non-occlusal stress-bearing class I restorations according to minimally invasive filling therapy

- Pit and fissure sealant.

- Tunnel-type preparation.

- Repair of enamel defects.

- Bonding of tooth fragments.

- Repairs in composite resin.

- Non-carious cervical lesions.

- Planning of preparation walls.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201707 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201707: Opallis, Opallis Flow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201707

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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