CONCISE LIGHT CURED WHITE SEALANT
FDA 510(k) clearance K844211 · decided 1985-01-07
Clearance details
- K-number
- K844211
- Device name
- CONCISE LIGHT CURED WHITE SEALANT
- Applicant
- 3M Company
- Decision
- Substantially Equivalent
- Date received
- 1984-10-31
- Decision date
- 1985-01-07
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- EBC
- Device class
- 2
- Regulation number
- 872.3765
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Cottae Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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| Helioseal F Plus (K190339) | Ivoclar Vivadent, AG | 2019-07-29 |
| Pulpdent (Activa) Pit and Fissure Sealant with MCP (K172169) | Pulpdent Corporation | 2018-01-05 |
| Nanova Sealant (K171330) | Nanova Biomaterials, Inc. | 2017-09-08 |
| HAPI Seal (K162598) | Bisco, Inc. | 2017-05-23 |
| Premier Sealant (K161580) | Premier Dental Company Products | 2016-10-18 |
| PACSEAL PIT & FISSURE SEALANT (K141717) | Pac-Dent International, Inc. | 2015-03-09 |
| CONTROL SEAL (K130485) | Voco GmbH | 2014-02-11 |
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 |