510(k) · Cleared
ClearedSanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scican GmbH · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Jan 31, 2014 as substantially equivalent to K071891 (Scican, Ltd., 2007) after a 186-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- Jan 31, 2014
- Review
- 186 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K071891 (2007). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK071891 Statis Dental HandpiecesScican, Ltd. · 2007 · Recalled
- This deviceK132356 Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso…Scican GmbH · 2014
- Descendant · cites it directly · 0 of its ownK240183 Star E900 Handpiece SeriesDentalez, Inc., Stardental Division · 2024
- Descendant · cites it directly · 0 of its ownK230106 General Cutting StraightNakanishi, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK222518 FX ContraNakanishi, Inc. · 2022
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 | K071891 | Statis Dental Handpieces | Scican, Ltd. | 2007 | 1 |
| 0 (this device) | K132356 | Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST | Scican GmbH | 2014 | — |
| +1 | K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | 2024 | — |
| +1 | K230106 | General Cutting Straight | Nakanishi, Inc. | 2023 | — |
| +1 | K222518 | FX Contra | Nakanishi, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 EGS? 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 EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · 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 |
|---|---|---|---|
| * | K071891 | Statis Dental HandpiecesSummary page 3…STAllS 1.5L SANAG 2001 (K07 1891) Picture( This medical device is. This medical device… | 2007 |
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?
- Its one ancestor has a recall.
- Of its descendants, K240183 (Dentalez, Inc., Stardental Division, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This medical device is only intended for dental treatment in the area of dentistry. It is intended to be used for the following applications:
- SANAO 200 L/140 ST: The removal of decayed matter, cavity and crown preparations, the removal of fillings and surface finishing of tooth and restoration surfaces.
- SANAO 40/40 L1/10/10 L: Cavity preparations, caries excavation, endodontics, surface finishing of tooth and restoration surfaces.
- SANAO PSI/PSO: prophylaxis treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132356 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132356: Sanao 200L, Sanao 40 /Sanao 40L, Sanao 10L, Sanao Psi / Sanao Pso, Sanao 40ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132356
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