GlasIonomer FX ULTRA— 510(k) K222253
Substantially EquivalentShofu Dental Corporation
FDA 510(k) clearance K222253 for GlasIonomer FX ULTRA, Substantially Equivalent on 2022-09-22. Applicant: Shofu Dental Corporation. Device class: 2.
Clearance details
- Applicant
- Shofu Dental Corporation
- 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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