Black Diamond
FDA 510(k) clearance K222323 · decided 2023-06-23
Clearance details
- K-number
- K222323
- Device name
- Black Diamond
- Applicant
- Elevate Oral Care, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-08-02
- Decision date
- 2023-06-23
- Days to decision
- 325 days
- Clearance type
- Traditional
- Product code
- PHR
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- West Palm Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SDF Pro (K250222) | Belport Company, Inc., Gingi-Pak | 2025-05-07 |
| Silver Fluoride Hypersensitivity Varnish (K241041) | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 |
| FAgamin® (K240059) | Tedequim Srl | 2024-05-16 |
| e-SDF (K240619) | Kids-E-Dental Llp | 2024-03-06 |
| Centrix FluoroSilver Silver Diamine Fluoride 38% (K222459) | Centrix, Inc. | 2023-10-27 |
| Riva Star (K172047) | Sdi Limited | 2018-04-11 |
| SILVER DENTAL ARREST (K102973) | Cooley Consulting, Inc. | 2014-07-31 |
Recalls involving this device
No recalls on record reference this clearance.