DENSEO FAIRY— 510(k) K082158
Substantially EquivalentXpdent Corp
FDA 510(k) clearance K082158 for DENSEO FAIRY, Substantially Equivalent on 2008-10-15. Applicant: Xpdent Corp. Device class: 2.
Clearance details
- Applicant
- Xpdent Corp
- Product code
- Code EIH
- Device class
- Class 2
- Regulation
- 21 CFR 872.6660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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