510(k) · Cleared
ClearedSinfony
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · EBF Material, Tooth Shade, Resin
Cleared on Sep 22, 1999 as substantially equivalent to K973513 (Espe GmbH & Co. Kg., 1997) and 6 other predicates after a 47-day review. Its family tree reaches back 3 generations to 1990. 59 later devices descend from it.
- Decided
- Sep 22, 1999
- Review
- 47 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K902115 (1990). 13 ancestors in all, the oldest K833757 (1984). 59 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK902115 Palapress (R) Vario ResinKulzer, Inc. · 1990
- 2 generations backK972573 Liqcrylic Pro Dental ResinDentsply Intl. · 1997
- 1 generation backK991220 Vitron HEspe Dental AG · 1999
- This deviceK992645 SinfonyEspe Dental AG · 1999
- Descendant · cites it directly · 35 of its ownK071131 UNO3M Espe AG Dental Products · 2007
- Descendant · 2 generations on · 34 of its ownK110302 Adhesive Exl-7593M Espe AG · 2011
- Descendant · cites it directly · 12 of its ownK042929 Estenia C&BKuraray Medical Kurashiki Plant · 2004
- Descendant · 3 generations on · 8 of its ownK112118 DreambondBisco, Inc. · 2011
- Descendant · 4 generations on · 6 of its ownK161051 All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K071131UNO3M Espe AG Dental Products · 2007 · cites it directly35descendants
- K110302Adhesive Exl-7593M Espe AG · 2011 · 2 generations on34descendants
- K042929Estenia C&BKuraray Medical Kurashiki Plant · 2004 · cites it directly12descendants
- K112118DreambondBisco, Inc. · 2011 · 3 generations on8descendants
- K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. · 2016 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902115 | Palapress (R) Vario Resin | Kulzer, Inc. | 1990 | — |
| −2 | K972573 | Liqcrylic Pro Dental Resin | Dentsply Intl. | 1997 | — |
| −1 | K991220 | Vitron H | Espe Dental AG | 1999 | — |
| 0 (this device) | K992645 | Sinfony | Espe Dental AG | 1999 | — |
| +1 | K071131 | UNO | 3M Espe AG Dental Products | 2007 | — |
| +2 | K110302 | Adhesive Exl-759 | 3M Espe AG | 2011 | — |
| +1 | K042929 | Estenia C&B | Kuraray Medical Kurashiki Plant | 2004 | — |
| +3 | K112118 | Dreambond | Bisco, Inc. | 2011 | — |
| +4 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 0 |
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
What was it cleared against? (7)
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 | Decided |
|---|---|---|---|
| * | K973513 | Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic…Summary page 1…de resin material Common Name:......cc.coovvmmmuirmnnnnnnennnns Crown and bridge veneering composite material Predicate Device SINFONY® (old version) by ESPE......... K 973513 TARGIS® system by IVOCLAR ............. K 962878 FiBrekoR® by JENERIC/PENTRON.... K 964578 PERTAC® Il by ESPE ...ocviveveveieee… | 1997 |
| * | K962878 | Targis SystemSummary page 1…irmnnnnnnennnns Crown and bridge veneering composite material Predicate Device SINFONY® (old version) by ESPE......... K 973513 TARGIS® system by IVOCLAR ............. K 962878 FiBrekoR® by JENERIC/PENTRON.... K 964578 PERTAC® Il by ESPE ...ocviveveveieeeneee K 962440 PROTEMP® GARANT by ESPE............… | 1996 |
| * | K964578 | FibrekorSummary page 1…composite material Predicate Device SINFONY® (old version) by ESPE......... K 973513 TARGIS® system by IVOCLAR ............. K 962878 FiBrekoR® by JENERIC/PENTRON.... K 964578 PERTAC® Il by ESPE ...ocviveveveieeeneee K 962440 PROTEMP® GARANT by ESPE................ K 950203 510(k) SINFONY® Page 2 of 81… | 1996 |
| * | K962440 | Pertac II/Pertac II AplitipSummary page 1…version) by ESPE......... K 973513 TARGIS® system by IVOCLAR ............. K 962878 FiBrekoR® by JENERIC/PENTRON.... K 964578 PERTAC® Il by ESPE ...ocviveveveieeeneee K 962440 PROTEMP® GARANT by ESPE................ K 950203 510(k) SINFONY® Page 2 of 81 [SIESPE VITRON®M by ESPE........cc… | 1996 |
| * | K950203 | Protemp (R) GarantSummary page 1…m by IVOCLAR ............. K 962878 FiBrekoR® by JENERIC/PENTRON.... K 964578 PERTAC® Il by ESPE ...ocviveveveieeeneee K 962440 PROTEMP® GARANT by ESPE................ K 950203 510(k) SINFONY® Page 2 of 81 [SIESPE VITRON®M by ESPE........ccoveereerennn. K 990763 VITRON®H by ESPE ..o, K 99… | 1995 |
| * | K990763 | Vitron MSummary page 2…cviveveveieeeneee K 962440 PROTEMP® GARANT by ESPE................ K 950203 510(k) SINFONY® Page 2 of 81 [SIESPE VITRON®M by ESPE........ccoveereerennn. K 990763 VITRON®H by ESPE ..o, K 991220 Description for the Premarket Notification SiNFONY® is classified as a tooth shade resin materia… | 1999 |
| * | K991220 | Vitron HSummary page 2…EMP® GARANT by ESPE................ K 950203 510(k) SINFONY® Page 2 of 81 [SIESPE VITRON®M by ESPE........ccoveereerennn. K 990763 VITRON®H by ESPE ..o, K 991220 Description for the Premarket Notification SiNFONY® is classified as a tooth shade resin material (21 C.F.R. § 872.3690) becaus… | 1999 |
What descends from it? (59)
See all 595 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K071131 (3M Espe AG Dental Products, 2007) has gone furthest, with 35 descendants of its own.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 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?
Full veneering of crowns and bridges
Complete crowns
Inlays/onlays
Fiber reinforced crowns and bridges
Direct bonded bridges
Telescopic and conical crowns
Attachments and implant works
Veneers
Long term temporary restorations and their characterization
Customization of acrylic and ceramic artificial teeth
Extraoral repairs
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/K992645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992645: Sinfony.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992645
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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