ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW— 510(k) K032355
Substantially EquivalentDentsply Gendex
FDA 510(k) clearance K032355 for ORTHORALIX 9200 DDE, ORTHORALIX 9200 DDE PLUS CEPH, MODELS 5105 0161WW, 5105 0181WW, Substantially Equivalent on 2003-09-25. Applicant: Dentsply Gendex. Device class: 2.
Clearance details
- Applicant
- Dentsply Gendex
- Product code
- Code EHD
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Des Plaines, IL, US
Recent devices under product code EHD
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