Product code MAU
- Device name
- Eraser, Dental Stain
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6855
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860012825516 | SmileDirectClub Whitening Pen - 9 Pack Plus Light | Ortho Dental Lab LLC | 2025-10-16 |
| 00860012825523 | SmileDirectClub Dissolving Strips | Ortho Dental Lab LLC | 2025-10-16 |
| 00860012825530 | SmileDirectClub Whitening Pen - 4 Pack Plus Light | Ortho Dental Lab LLC | 2025-10-16 |
| 00860012825547 | SmileDirectClub Whitening Refill - 8 Pack | Ortho Dental Lab LLC | 2025-10-16 |
| 00860012825561 | SmileDirectClub Whitening plus Lip Balm - 4 Pack | Ortho Dental Lab LLC | 2025-10-16 |
| 00850078989154 | SmileSet Premium Whitening Refill – 4 Pack | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989178 | SmileSet Premium Sensitive Whitening Strips | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989161 | SmileSet Premium Whitening Sample Pen – 3 ml | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989147 | SmileSet Premium Whitening Kit – White | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989130 | SmileSet Premium Whitening Kit – Mint | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989123 | SmileSet Premium Whitening Kit – Black | Ortho Dental Lab LLC | 2025-09-25 |
| 00353238006208 | Perio Sciences LED Tooth Whitener | Perio Sciences, LLC | 2024-02-08 |
| 00353238106212 | Perio Sciences Replacement Tooth Whitening Pens | Perio Sciences, LLC | 2024-02-08 |
| 06970016621824 | Non | Jiangxi Dentalbright Technology Co., Ltd | 2023-05-06 |
| 07506338301480 | MDC Dental | MDC DENTAL | 2023-05-04 |
| 06970016623651 | Daniel | Jiangxi Dentalbright Technology Co., Ltd | 2023-03-25 |
| 06970016622920 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016622807 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016622005 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016621879 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016621831 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016621534 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016621404 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2023-02-22 |
| 06970016620643 | GlorySmile | Jiangxi Dentalbright Technology Co., Ltd | 2022-12-21 |
| 00889813048566 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2022-07-18 |
| 00889813048580 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2022-07-18 |
| 00889813048610 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2022-07-18 |
| 00889813048672 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2022-07-18 |
| 00889813048696 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2022-07-18 |
| 00889813048719 | Darby Dental Supply, LLC | DARBY DENTAL SUPPLY, LLC | 2022-07-18 |