Calcium Bridge— 510(k) K153191
Substantially EquivalentDenali Corporation
FDA 510(k) clearance K153191 for Calcium Bridge, Substantially Equivalent on 2016-02-26. Applicant: Denali Corporation. Device class: 2.
Clearance details
- Applicant
- Denali Corporation
- 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
- Hanover, MA, US
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