510(k) · Cleared
ClearedClinpro Prophy Powder
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 Oct 24, 2014 as substantially equivalent to K110379 (Satelec, 2011) and 1 other predicate after a 220-day review. Its family tree reaches back 5 generations to 1990. 1 later device descends from it.
- Decided
- Oct 24, 2014
- Review
- 220 days
- Class
- Class II
- Product code
- PIP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K900709 (1990). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
- 4 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
- 3 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
- 2 generations backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
- 1 generation backK110379 Air-N-GOSatelec · 2011
- This deviceK140684 Clinpro Prophy Powder3M Deutschland GmbH · 2014
- Descendant · cites it directly · 0 of its ownK151748 Clean & More3M Deutschland GmbH · 2016
Most influential descendants
Showing 1 of 1 · See all- K151748Clean & More3M Deutschland GmbH · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900709 | Air Flow Sii | Electro Medical Systems (Ems Sa) | 1990 | — |
| −4 | K991857 | Airflow Handy | Electro Medical Systems, Inc. | 1999 | — |
| −3 | K022119 | Ems Air-Flow Handy 2 Dental Handpiece | Electro Medical Systems SA | 2002 | — |
| −2 | K092289 | Ems Air-Flow Handy Perio | E.M.S Electro Medical Systems S.A | 2009 | — |
| −1 | K110379 | Air-N-GO | Satelec | 2011 | — |
| 0 (this device) | K140684 | Clinpro Prophy Powder | 3M Deutschland GmbH | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K110379 | Air-N-GOSummary page 4…............ Prophy Powder, Airbrush Accessory Regulation Number: ........................................ 21 CFR 872.6080 Predicate Devices Air-N-Go® Perio Powder: K110379 by Satelec – Acteon Group, France Air-Flow® Perio Powder: K092289 by EMS Electro Medical Systems SA, Switzerland… | 2011 |
| * | K092289 | Ems Air-Flow Handy PerioSummary page 4…........................................ 21 CFR 872.6080 Predicate Devices Air-N-Go® Perio Powder: K110379 by Satelec – Acteon Group, France Air-Flow® Perio Powder: K092289 by EMS Electro Medical Systems SA, Switzerland Description for the Premarket Notification… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151748 | Clean & More | 2016 | 0 |
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 24 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K151748 (3M Deutschland GmbH, 2016) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K110379.
How does its category compare?
All PIP devicesPIP Prophy Powder, Airbrush Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
• Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
• For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
• For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
Calculi and tartar cannot be removed with Clinpro Prophy Powder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140684 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140684: Clinpro Prophy Powder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140684
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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