Devices

Device Recall Perioscopy Sheath

Model / Serial
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.
Product Classification
Dental Devices
Device Class
1
Implanted device?
No
Distribution
US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
Product Description
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).
Manufacturer
Danville Materials, Inc.
1 Event
- Recall of Device Recall Perioscopy Sheath

Manufacturer

Danville Materials, Inc.

Manufacturer Address
Danville Materials, Inc., 3420 Fostoria Way Ste A200, San Ramon CA 94583-1327
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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