SOOTHE-N-SEAL CANKER SORE RELIEF
FDA 510(k) clearance K991923 · decided 1999-09-02
Clearance details
- K-number
- K991923
- Device name
- SOOTHE-N-SEAL CANKER SORE RELIEF
- Applicant
- Closure Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-07
- Decision date
- 1999-09-02
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- MZW
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Raleigh, NC, 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 |
|---|---|---|
| MAXCEM 2 (K073209) | Kerr Corporation | 2008-01-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S012) | Closure Medical Corp. | 2006-09-14 |
| HIGH VISCOSITY DERMABOND MINI APPLICATOR (P960052/S011) | Closure Medical Corp. | 2006-02-10 |
| HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE (P960052/S010) | Closure Medical Corp. | 2005-03-21 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S009) | Closure Medical Corp. | 2004-09-24 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S007) | Closure Medical Corp. | 2003-12-01 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S006) | Closure Medical Corp. | 2003-06-13 |
| DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY (P960052/S004) | Closure Medical Corp. | 2002-12-31 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S005) | Closure Medical Corp. | 2002-07-24 |