510(k) · Cleared
ClearedPlaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kevin Vu, Dds · EMN Scaler, Periodontic
Cleared on Mar 29, 2007 as substantially equivalent to K963747 (Whitehill Manufacturing, Inc., 1996) after a 72-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 29, 2007
- Review
- 72 days
- Class
- Class I
- Product code
- EMN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963747 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963747 Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks…Whitehill Manufacturing, Inc. · 1996
- This deviceK070127 Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model…Kevin Vu, Dds · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963747 | Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks with… | Whitehill Manufacturing, Inc. | 1996 | — |
| 0 (this device) | K070127 | Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02 | Kevin Vu, Dds | 2007 | — |
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 EMN? 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 |
|---|---|---|---|
| * | K963747 | Reach Stim-U-Dent Plaque Removers with Microdent/Reach Floss Stiks with Microdent/Reach…Summary page 2…~~Number K963747 A Interproximal Plaque Remover Manufacturing, Inc. (between teeth) Plaque Remover 5.0… | 1996 |
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?
- Its one ancestor has no recall.
How does its category compare?
All EMN devicesEMN Scaler, Periodontic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · EMN
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · EMN
Too few EMN 510(k)s in any year since 2007 to give a median.
Recalls per year · EMN
No recall names EMN since 2007.
Adverse event reports per year · EMN
2in 2025
MAUDE reports naming product code EMN, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Plaque Scraper-A Interproximal (between teeth) Plaque Remover is an
effective cleansing device which removes plaque and food between the teeth as
part of a program for good oral hygiene to supplement the regular professional
care required for oral health. This product is intended for personal oral hygiene
use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070127: Plaque Scraper-a Interproximal (Between Teeth) Plaque Remover, Model Z01, Z02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070127
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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