510(k) · Cleared
ClearedLubrina, Model Him-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on May 31, 2007 as substantially equivalent to K012308 (Kavo America, 2002) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- May 31, 2007
- Review
- 143 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010127 (2001). 2 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010127 W & H AssistinaA-Dec, Inc. · 2001
- This deviceK070074 Lubrina, Model Him-1J. Morita USA, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK190509 Lubrina 2J. Morita USA, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK103697 TorqtechJ. Morita USA, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK093072 Starcare Handpiece Maintenance UnitDentalez, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010127 | W & H Assistina | A-Dec, Inc. | 2001 | — |
| 0 (this device) | K070074 | Lubrina, Model Him-1 | J. Morita USA, Inc. | 2007 | — |
| +1 | K190509 | Lubrina 2 | J. Morita USA, Inc. | 2020 | — |
| +1 | K103697 | Torqtech | J. Morita USA, Inc. | 2012 | — |
| +1 | K093072 | Starcare Handpiece Maintenance Unit | Dentalez, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K012308 | Kavo QuattrocareSummary page 2…the device is designed in a similar structure and performance. · Predicate device The HIM-1 is substantially equivalent to the Kavo QUATTROcare from KaVo America (K #012308) and the W & H Assistina from A-Dec, Inc. ( K #010127). The HIM-I has similar general intended uses, similar principles of operat… | 2002 |
| * | K010127 | W & H AssistinaSummary page 2…formance. · Predicate device The HIM-1 is substantially equivalent to the Kavo QUATTROcare from KaVo America (K #012308) and the W & H Assistina from A-Dec, Inc. ( K #010127). The HIM-I has similar general intended uses, similar principles of operation, and similar technological characteristics as the… | 2001 |
What descends from it? (3)
3 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 EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
LUBRINA HIM-I is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: LUBRiNA HIM-1 should be used only with pre-cleaned dental handpieces and before they are sterilized.
CAUTION: FEDERAL (US) law restricts the use of this device to licensed professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070074 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070074: Lubrina, Model Him-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070074
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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