3M Clarity Aligners
FDA 510(k) clearance K192119 · decided 2019-09-05
Clearance details
- K-number
- K192119
- Device name
- 3M Clarity Aligners
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 2019-08-06
- Decision date
- 2019-09-05
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- NXC
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Saint Paul, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011) | 3M Company | 1994-11-28 |
| CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010) | 3M Company | 1994-05-19 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006) | 3M Company | 1992-12-31 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009) | 3M Company | 1992-03-13 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008) | 3M Company | 1992-01-28 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007) | 3M Company | 1990-10-17 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005) | 3M Company | 1990-03-08 |
| KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004) | 3M Company | 1989-11-22 |