510(k) · Cleared
ClearedSpectrum 800 Curing Unit
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 Sep 15, 1998 as substantially equivalent to K951425 (Dentsply Intl., 1995) after a 75-day review. Its family tree reaches back 1 generation to 1995. 16 later devices descend from it.
- Decided
- Sep 15, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951425 (1995). 16 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- This deviceK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- Descendant · cites it directly · 13 of its ownK031615 Sled Curing Light SystemDentsply International · 2003
- Descendant · cites it directly · 12 of its ownK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- Descendant · 2 generations on · 7 of its ownK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- Descendant · 3 generations on · 6 of its ownK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- Descendant · 4 generations on · 2 of its ownK090925 Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K031615Sled Curing Light SystemDentsply International · 2003 · cites it directly13descendants
- K041372Smartlite PS Pen-Style Led Curing LightDentsply International · 2004 · cites it directly12descendants
- K063529Pencure, Model VL-7J. Morita USA, Inc. · 2007 · 2 generations on7descendants
- K071190Root ZX IIJ. Morita USA, Inc. · 2007 · 3 generations on6descendants
- K090925Multiple (Apex Locator), Model RCM-7J. Morita USA, Inc. · 2009 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| 0 (this device) | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| +1 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| +1 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| +2 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| +3 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| +4 | K090925 | Multiple (Apex Locator), Model RCM-7 | J. Morita USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K951425 | Spectrum Curing Light Polymerization UnitSummary page 1…SPECTRUM™ 800 CURING UNIT CLASSIFICATION NAME: Unclassified COMMON OR USUAL NAME: Visible light activator for polymerization PREDICATE DEVICES: Spectrum™ Curing Light K951425 DEVICE DESCRIPTION: The SPECTRUM™ 800 CURING UNIT is a visible light emitting photopolymerization unit that produces light used… | 1995 |
What descends from it? (16)
See all 164 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?
- Its one ancestor has no recall.
- Of its descendants, K031615 (Dentsply International, 2003) has gone furthest, with 13 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?
The SPECTRUM™ 800 CURING UNIT provides visible light irradiation for the
curing of dental VLC resin products.
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/K982318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982318: Spectrum 800 Curing Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982318
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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