510(k) · Cleared
ClearedClean & More
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Deutschland GmbH · PIP Prophy Powder, Airbrush Accessory
Cleared on Mar 11, 2016 as substantially equivalent to K140684 (3M Deutschland GmbH, 2014) after a 256-day review. Its family tree reaches back 6 generations to 1990.
- Decided
- Mar 11, 2016
- Review
- 256 days
- Class
- Class II
- Product code
- PIP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K900709 (1990). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 5 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 4 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- 3 generations backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- 2 generations backK110379 Air-N-GOSatelec · 2011
- 1 generation backK140684 Clinpro Prophy Powder3M Deutschland GmbH · 2014
- This deviceK151748 Clean & More3M Deutschland GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −5 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −4 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| −3 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| −2 | K110379 | Air-N-GO | Satelec | 2011 | — |
| −1 | K140684 | Clinpro Prophy Powder | 3M Deutschland GmbH | 2014 | — |
| 0 (this device) | K151748 | Clean & More | 3M Deutschland GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 PIP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K140684 | Clinpro Prophy PowderSummary page 5…ion Number: ....................................... 21 CFR 872.6080 Predicate Devices Primary Predicate Device Clinpro Prophy Powder .................................. K140684 ............................................................ by 3M Deutschland GmbH, Germany Product Code: ...............… | 2014 |
| † | K062502 | Osspray Cleaning Compound | 2006 |
| † | K092141 | Vanish Varnish, 5% Sodium Fluoride White Varnish | 2010 |
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 26 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All PIP devicesPIP Prophy Powder, Airbrush Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PIP
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PIP
Too few PIP 510(k)s in any year since 2007 to give a median.
Recalls per year · PIP
No recall names PIP since 2007.
Adverse event reports per year · PIP
No MAUDE report names PIP since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains
Professional cleaning of teeth including patients with dentin hypersensitivity
Treatment of dentin hypersensitivity by blockage of the dentin tubules
Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants
For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
For maintenance in periimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
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/K151748 · printed Nov 5, 2026
Cite this page
510(k) Report. “K151748: Clean & More.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K151748
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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