FR ROOT CANAL SEALER— 510(k) K830764
Substantially EquivalentShizai Corp.
FDA 510(k) clearance K830764 for FR ROOT CANAL SEALER, Substantially Equivalent on 1983-07-26. Applicant: Shizai Corp.. Device class: 1.
Clearance details
- Applicant
- Shizai Corp.
- Product code
- Code EKA
- Device class
- Class 1
- Regulation
- 21 CFR 872.4565
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code EKA
view allMore clearances from Shizai Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.