510(k) K222323
- Device
- Black Diamond
- Applicant
- Elevate Oral Care, LLC
- 510(k) number
- K222323
- Product code
- PHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-23
- Date received
- 2022-08-02
- Regulation
- 872.3260
- Classification name
- Diammine Silver Fluoride Dental Hypersensitivity Varnish
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Steve Pardue
- Address
- 346 Pike Rd. Suite 5 West Palm Beach FL US 33411 33411
FDA Registration Numbers#
- 3007113445
- 3020703838
- 3014615644
- 3004140838
- 1941138
- 1281412
- 3027618252
- 3003130442
- 3006444232
- 3009603151
Source Documents#
Other 510(k) Records For Product Code PHR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250222 | SDF Pro | Belport Company, Inc., Gingi-Pak | 2025-05-07 |
| K241041 | Silver Fluoride Hypersensitivity Varnish | Young Dental Manufacturing Co. 1, LLC | 2025-02-28 |
| K240059 | FAgamin® | Tedequim Srl | 2024-05-16 |
| K240619 | e-SDF | Kids-E-Dental Llp | 2024-03-06 |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | 2023-10-27 |
| K172047 | Riva Star | Sdi Limited | 2018-04-11 |
| K102973 | SILVER DENTAL ARREST | Cooley Consulting, Inc. | 2014-07-31 |