2 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
FDA Recall
Terminated
·Danville Materials, Inc.·Product code EIA·June 24, 2016
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
FDA Enforcement
Class II
·Terminated·Danville Materials, Inc.·August 24, 2016