HY-BOND RESIGLASS— 510(k) K111855
Substantially EquivalentShofu Dental Corp.
FDA 510(k) clearance K111855 for HY-BOND RESIGLASS, Substantially Equivalent on 2011-11-17. 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
- San Marcos, CA, US
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