510(k) · Cleared
Recalled · 2006Kavo Quattrocare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America · EFB Handpiece, Air-Powered, Dental
Cleared on Jun 26, 2002 after a 338-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 26, 2002
- Review
- 338 days
- Class
- Class I
- Product code
- EFB
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK012308 Kavo QuattrocareKavo America · 2002
- Descendant · cites it directly · 3 of its ownK070074 Lubrina, Model Him-1J. Morita USA, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK190509 Lubrina 2J. Morita USA, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK103697 TorqtechJ. Morita USA, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK093072 Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K070074Lubrina, Model Him-1J. Morita USA, Inc. · 2007 · cites it directly3descendants
- K190509Lubrina 2J. Morita USA, Inc. · 2020 · 2 generations on0descendants
- K103697TorqtechJ. Morita USA, Inc. · 2012 · cites it directly0descendants
- K093072Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012308 | Kavo Quattrocare | Kavo America | 2002 | — |
| +1 | K070074 | Lubrina, Model Him-1 | J. Morita USA, Inc. | 2007 | — |
| +2 | K190509 | Lubrina 2 | J. Morita USA, Inc. | 2020 | — |
| +1 | K103697 | Torqtech | J. Morita USA, Inc. | 2012 | — |
| +2 | K093072 | Starcare Handpiece Maintenance Unit | Dentalez, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 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? (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 |
|---|---|---|---|
| * | — | KaVo Spray Named without a submission number |
What descends from it? (4)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2006 | Not classified | Z-0289-2007 | Other | The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070074 (J. Morita USA, Inc., 2007) has gone furthest, with 3 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
KaVo QUATTROcare is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012308: Kavo Quattrocare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012308
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026