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510(k) Data Aggregation
K Number
K113497Device Name
HYPERION
Manufacturer
Date Cleared
2012-01-17
(53 days)
Product Code
Regulation Number
872.1800Why did this record match?
Applicant Name (Manufacturer) :
CEFLA S.C. CEFLA DENTAL GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The hyperion is a digital panoramic and cephalometric extra-oral X-ray system, indicated for use in:
- producing panoramic X-ray images of the maxillofacial area, for (i) diagnostic examination of dentition (teeth), jaws and oral structures; and
- · producing radiographs of the jaws and parts of the skull, for the (ii) purpose of cephalometric examination if equipped with CEPH arm.
Device Description
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