FDA-Device2016-08-24Class II
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).
Danville Materials, Inc.
Hazard
The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Sold states
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
Affected count
~ 2123 units
Manufactured in
3420 Fostoria Way Ste A200, N/A, San Ramon, CA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2530-2016Don't want to check this manually?
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