FR ROOT CANAL SEALER
FDA 510(k) clearance K830764 · decided 1983-07-26
Clearance details
- K-number
- K830764
- Device name
- FR ROOT CANAL SEALER
- Applicant
- Shizai Corp.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-10
- Decision date
- 1983-07-26
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- EKA
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| OBTURATION GUTTA (K822464) | U.S. Shizai Corp. | 1982-11-03 |
Recalls involving this device
No recalls on record reference this clearance.