510(k) · Cleared
ClearedNexcomp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed Co., Ltd. · EBF Material, Tooth Shade, Resin
Cleared on Nov 15, 2018 as substantially equivalent to K080305 (Meta Biomed Co., Ltd., 2008) after a 142-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Nov 15, 2018
- Review
- 142 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K863092 (1986). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK863092 Dental Composite RestorativeDentsply Intl. · 1986
- 4 generations backK973221 Composite 168 Restorative SystemDentsply Intl. · 1998
- 3 generations backK984387 R-30 Aesthetic RestorativeDentsply Intl. · 1999
- 2 generations backK052097 Ceram X Universal Mano-Ceramic RestorativeDentsply International · 2005
- 1 generation backK080305 Nexcomp and Meta EtchantMeta Biomed Co., Ltd. · 2008
- This deviceK181689 NexcompMeta Biomed Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K863092 | Dental Composite Restorative | Dentsply Intl. | 1986 | — |
| −4 | K973221 | Composite 168 Restorative System | Dentsply Intl. | 1998 | — |
| −3 | K984387 | R-30 Aesthetic Restorative | Dentsply Intl. | 1999 | — |
| −2 | K052097 | Ceram X Universal Mano-Ceramic Restorative | Dentsply International | 2005 | — |
| −1 | K080305 | Nexcomp and Meta Etchant | Meta Biomed Co., Ltd. | 2008 | — |
| 0 (this device) | K181689 | Nexcomp | Meta Biomed Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K080305 | Nexcomp and Meta EtchantSummary page 4…evice Class: Class II • Date prepared: 11/08/2018 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: • K080305, Nexcomp manufactured by Meta Biomed Co., Ltd. General Description Nexcomp is a light-cured, esthetic, resin-based dental resto… | 2008 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
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?
Nexcomp is intended to restore carious lesions or structural defects in teeth. It is indicated for Class 1, II, Ill, IV, and V
restorations, core-buildup to replace missing tooth structure, for splinting and for diasterna closure. direct veneers,
composite and porcelain repairs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181689: Nexcomp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181689
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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