510(k) · Cleared
ClearedCrest Glide Clinical Gum Protection Dental Floss
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procter & Gamble Co. · JES Floss, Dental
Cleared on Sep 24, 2009 as substantially equivalent to K073224 (Procter & Gamble, 2008) after an 85-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Sep 24, 2009
- Review
- 85 days
- Class
- Class I
- Product code
- JES
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921773 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921773 TX Electric ToothbrushOptiva Corp. · 1992
- 3 generations backK040416 Sonicare Advance Toothbrush, Model 4900Philips Oral Healthcare, Inc. · 2004
- 2 generations backK061351 Oral-B Sonic CompleteBraun GmbH · 2006
- 1 generation backK073224 Oral-B Sub-Brand Manual ToothbrushProcter & Gamble · 2008
- This deviceK091964 Crest Glide Clinical Gum Protection Dental FlossProcter & Gamble Co. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921773 | TX Electric Toothbrush | Optiva Corp. | 1992 | — |
| −3 | K040416 | Sonicare Advance Toothbrush, Model 4900 | Philips Oral Healthcare, Inc. | 2004 | — |
| −2 | K061351 | Oral-B Sonic Complete | Braun GmbH | 2006 | — |
| −1 | K073224 | Oral-B Sub-Brand Manual Toothbrush | Procter & Gamble | 2008 | — |
| 0 (this device) | K091964 | Crest Glide Clinical Gum Protection Dental Floss | Procter & Gamble Co. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 JES? 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 |
|---|---|---|---|
| * | K073224 | Oral-B Sub-Brand Manual ToothbrushSummary page 1…tion): JES (Class I, 21CFR 872.6390) Legally Marketed Predicate Devices: Glide Comfort Plus Dental Floss Oral-B Toothbrush (K073224) Device Description and Technical Characteristics: Crest Glide dental floss is a manual dental floss comprised of polytetrafluo… | 2008 |
| * | — | Glide Comfort Plus Dental Floss Named without a submission number |
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 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K073224.
How does its category compare?
All JES devicesJES Floss, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JES
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · JES
Too few JES 510(k)s in any year since 2007 to give a median.
Recalls per year · JES
No recall names JES since 2007.
Adverse event reports per year · JES
5in 2025
MAUDE reports naming product code JES, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 23 |
| 2012 | 0 | — | 0 | 98 |
| 2013 | 0 | — | 0 | 75 |
| 2014 | 0 | — | 0 | 84 |
| 2015 | 0 | — | 0 | 45 |
| 2016 | 0 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 50 |
| 2018 | 0 | — | 0 | 52 |
| 2019 | 0 | — | 0 | 52 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
To remove plaque and food particles from between the teeth as part of a comprehensive dental treatment program to reduce tooth decay and to treat and prevent gingivitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091964: Crest Glide Clinical Gum Protection Dental Floss.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091964
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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