EDS Bioceramic Sealer (Bioseal)— 510(k) K202281
Substantially EquivalentEssential Dental Systems
FDA 510(k) clearance K202281 for EDS Bioceramic Sealer (Bioseal), Substantially Equivalent on 2021-02-12. Applicant: Essential Dental Systems. Device class: 2.
Clearance details
- Applicant
- Essential Dental Systems
- Product code
- Code KIF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3820
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Hackensack, NJ, US
Recent devices under product code KIF
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