HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE— 510(k) K945451
Substantially EquivalentShofu Dental Corp.
FDA 510(k) clearance K945451 for HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE, Substantially Equivalent on 1995-02-27. Applicant: Shofu Dental Corp.. Device class: 2.
Clearance details
- Applicant
- Shofu Dental Corp.
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
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