BRUSH, APPLICATOR
FDA 510(k) clearance K781098 · decided 1978-09-29
Clearance details
- K-number
- K781098
- Device name
- BRUSH, APPLICATOR
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1978-07-03
- Decision date
- 1978-09-29
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- KXR
- Device class
- 1
- Regulation number
- 872.3140
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- White City, OR, 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 |
|---|---|---|
| DENTAL SYRINGE SYSTEM-VARIOUS STYLES (K832662) | Centrix, Inc. | 1983-10-04 |
| CERAMIST BRUSH (K770160) | Deringer-Ney, Inc. | 1977-01-31 |
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 |