Renamel Bulkfill— 510(k) K211259
Substantially EquivalentCosmedent, Inc.
FDA 510(k) clearance K211259 for Renamel Bulkfill, Substantially Equivalent on 2021-06-24. Applicant: Cosmedent, Inc.. Device class: 2.
Clearance details
- 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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