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DTX Studio™ Clinic

Nobel Biocare AB · Model 4.3 · UDI-DI 07332747215212

MYNLLZ Prescription
1
510(k) clearances
5
Adverse events
3
Recalls
28
Facilities

Description

DTX Studio Clinic 4.3 for Win 64-bit

Recalls

DateFirmReason
2015-04-06GA IndustriesGA Industries is recalling the Logicon Caries Detector, version 5.0, for Carestream Dental because it was not submitted for approval to the FDA prior to product release.
2006-05-04Riverain Medical GroupThe device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0
2006-05-04Riverain Medical GroupThe device has an actual sensitivity of 58.2% and a specificity of 3.9% (false positives per image). The product is approved to have a sensitivity of 63.3% and a specificity of 5.0

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.