FISSURE SEALER— 510(k) K913853
Substantially EquivalentOrtho Source
FDA 510(k) clearance K913853 for FISSURE SEALER, Substantially Equivalent on 1992-08-27. Applicant: Ortho Source. Device class: 2.
Clearance details
- Applicant
- Ortho Source
- Product code
- Code EBC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3765
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Hollywood, CA, US
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