510(k) · Cleared
ClearedTutu 7, Model IV-T22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invisible Technology Co., Ltd. · EBZ Activator, Ultraviolet, For Polymerization
Cleared on Oct 27, 2006 as substantially equivalent to K041372 (Dentsply International, 2004) and 1 other predicate after a 44-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Oct 27, 2006
- Review
- 44 days
- Class
- Class II
- Product code
- EBZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K951425 (1995). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 3 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 2 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 1 generation backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- This deviceK062735 Tutu 7, Model IV-T22Invisible Technology Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −3 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −2 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −1 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| 0 (this device) | K062735 | Tutu 7, Model IV-T22 | Invisible Technology Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 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 EBZ? 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 EBZ device
- #1 K253131 Curing Light (M-Cure 6)score 12.7 · 5 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 |
|---|---|---|---|
| * | K041372 | Smartlite PS Pen-Style Led Curing LightSummary page 1…lassification Number: EBZ 807.92(a)(3) Predicate Device(s) Dentsply International SmartLite PS Pen-Style K041372 LED Curing Light 3M ESPE AG Elipar FreeLight K01 11 54… | 2004 |
| * | K011154 | Elipar FreelightSummary page 1…SmartLite PS Pen-Style K041372 LED Curing Light 3M ESPE AG Elipar FreeLight K01 11 54 17 5 10(k) Summary Invis… | 2001 |
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 11 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K041372.
How does its category compare?
All EBZ devicesEBZ Activator, Ultraviolet, For Polymerization: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBZ
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBZ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBZ
1in 2025
MAUDE reports naming product code EBZ, 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 | 10 | 47 | 0 | 1 |
| 2008 | 5 | 75 | 0 | 7 |
| 2009 | 4 | 69 | 0 | 5 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 3 | 137 | 0 | 18 |
| 2012 | 1 | — | 1 | 20 |
| 2013 | 3 | 171 | 0 | 27 |
| 2014 | 3 | 289 | 0 | 31 |
| 2015 | 4 | 252 | 0 | 8 |
| 2016 | 4 | 251 | 0 | 3 |
| 2017 | 8 | 158 | 0 | 5 |
| 2018 | 2 | — | 1 | 3 |
| 2019 | 5 | 145 | 0 | 0 |
| 2020 | 5 | 164 | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 5 | 144 | 1 | 5 |
| 2023 | 3 | 255 | 0 | 7 |
| 2024 | 1 | — | 0 | 3 |
| 2025 | 4 | 105 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TUTU TM LED intraoral curing light is designed to polymerize visible light cure (VLC) dental materials including dental pit and fissure sealants, bonding adhesives, cements, restorative or luting materials
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062735: Tutu 7, Model IV-T22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062735
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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