Fixtemp Cement— 510(k) K142446
Substantially EquivalentExacta Dental Direct, Inc.
FDA 510(k) clearance K142446 for Fixtemp Cement, Substantially Equivalent on 2015-06-04. Applicant: Exacta Dental Direct, Inc.. Device class: 2.
Clearance details
- Applicant
- Exacta Dental Direct, Inc.
- 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
- Clinton Township, MI, US
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