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).

Reason: 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.

Code information: Part number 1008: Lot numbers: 1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173; 1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1; 1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.

Distribution pattern: US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.