510(k) · Cleared
ClearedBlack Diamond
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elevate Oral Care, LLC · PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish
Cleared on Jun 23, 2023 as substantially equivalent to K102973 (Cooley Consulting, Inc., 2014) after a 325-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Jun 23, 2023
- Review
- 325 days
- Class
- Class II
- Product code
- PHR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K102973 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK102973 Silver Dental ArrestCooley Consulting, Inc. · 2014
- This deviceK222323 Black DiamondElevate Oral Care, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K102973 | Silver Dental Arrest | Cooley Consulting, Inc. | 2014 | — |
| 0 (this device) | K222323 | Black Diamond | Elevate Oral Care, LLC | 2023 | — |
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 PHR? 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 PHR device
- #1 K241041 Silver Fluoride Hypersensitivity Varnishscore 8.9 · 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.
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.
- 5 other devices also cite its predicate K102973.
How does its category compare?
All PHR devicesPHR Diammine Silver Fluoride Dental Hypersensitivity Varnish: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PHR
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHR
Too few PHR 510(k)s in any year since 2007 to give a median.
Recalls per year · PHR
No recall names PHR since 2007.
Adverse event reports per year · PHR
1in 2023
MAUDE reports naming product code PHR, 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 | 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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Black Diamond is intended as Treatment of Dental Hypersensitivity. For use in adults over the age of 21.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222323: Black Diamond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222323
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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