Renamel® Microhybrid; Renamel® Flowable Microhybrid— 510(k) K222435
Substantially EquivalentCosmedent, Inc.
FDA 510(k) clearance K222435 for Renamel® Microhybrid; Renamel® Flowable Microhybrid, Substantially Equivalent on 2022-10-11. Applicant: Cosmedent, Inc.. Device class: 2.
Clearance details
- Device name as filed
- Renamel® Microhybrid ;Renamel® Flowable Microhybrid
- Applicant
- Cosmedent, Inc.
- Product code
- Code EBF
- Device class
- Class 2
- Regulation
- 21 CFR 872.3690
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
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