510(k) · Cleared
ClearedComposite 168 Restorative System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EBF Material, Tooth Shade, Resin
Cleared on Feb 9, 1998 as substantially equivalent to K863092 (Dentsply Intl., 1986) and 1 other predicate after a 166-day review. Its family tree reaches back 1 generation to 1986. 102 later devices descend from it.
- Decided
- Feb 9, 1998
- Review
- 166 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863092 (1986). 2 ancestors in all. 102 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK863092 Dental Composite RestorativeDentsply Intl. · 1986
- This deviceK973221 Composite 168 Restorative SystemDentsply Intl. · 1998
- Descendant · cites it directly · 93 of its ownK984201 DenzirDentronic AB · 1999
- Descendant · 2 generations on · 91 of its ownK023327 Cynovad ZirkonCynovad · 2002
- Descendant · 2 generations on · 80 of its ownK043472 Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005
- Descendant · 2 generations on · 76 of its ownK062695 Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006
- Descendant · 3 generations on · 43 of its ownK081850 Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008
Showing 5 of 102 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 102 · See all- K984201DenzirDentronic AB · 1999 · cites it directly93descendants
- K023327Cynovad ZirkonCynovad · 2002 · 2 generations on91descendants
- K043472Medin Tech Zirconia-CP10, SS1000Medin Tech · 2005 · 2 generations on80descendants
- K062695Sagemax Z-BlankSagemax Bioceramics, Inc. · 2006 · 2 generations on76descendants
- K081850Bisque Zirconia Blanks, Type ByzZircar Zirconia, Inc. · 2008 · 3 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863092 | Dental Composite Restorative | Dentsply Intl. | 1986 | — |
| 0 (this device) | K973221 | Composite 168 Restorative System | Dentsply Intl. | 1998 | — |
| +1 | K984201 | Denzir | Dentronic AB | 1999 | — |
| +2 | K023327 | Cynovad Zirkon | Cynovad | 2002 | — |
| +2 | K043472 | Medin Tech Zirconia-CP10, SS1000 | Medin Tech | 2005 | — |
| +2 | K062695 | Sagemax Z-Blank | Sagemax Bioceramics, Inc. | 2006 | — |
| +3 | K081850 | Bisque Zirconia Blanks, Type Byz | Zircar Zirconia, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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? (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 | Decided |
|---|---|---|---|
| * | K863092 | Dental Composite RestorativeSummary page 1…168 RESTORATIVE SYSTEM COMMON OR USUAL NAME: Dental restorative material CLASSIFICATION NAME: Tooth resin shade material PREDICATE DEVICE: Dental Composite Restorative K863092 SDI Composites K941899 DEVICE DESCRIPTION: COMPOSITE 168 RESTORATIVE is a visible light activated, radiopaque restorative materi… | 1986 |
| * | K941899 | Sdi CompostiesSummary page 1…COMMON OR USUAL NAME: Dental restorative material CLASSIFICATION NAME: Tooth resin shade material PREDICATE DEVICE: Dental Composite Restorative K863092 SDI Composites K941899 DEVICE DESCRIPTION: COMPOSITE 168 RESTORATIVE is a visible light activated, radiopaque restorative material for anterior and pos… | 1994 |
What descends from it? (102)
See all 1025 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?
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?
COMPOSITE 168 RESTORATIVE SYSTEM is to be used with Prime & Bond™ 2.1 Universal Light Cured Dental Adhesive System:
Indicated for cavity Classes I, II, III, IV, V, and VI in anterior and posterior teeth.
May be used as a direct restorative material
May be used for fabrication of inlays and onlays
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/K973221 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973221: Composite 168 Restorative System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973221
Report an extraction error
Are you the manufacturer?
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