6 results
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16ms
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Sources: EU EUDAMED, US FDA
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Country: Italy
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Eumed s.r.l.
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🇮🇹 Italy·2 Manufacturers·14 Devices
Omnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model: 32.Z2000.00, 32.Z2002.00, 32.Z2004.00, 32.Z2006.00, 32.Z2007.00, 32.Z2008.00, 32.Z2009.00, 32.Z2020.00, 32.Z2022.00, 32.Z2024.00, 32.Z2026.00, 32.Z2027.00, 32.Z2028.00, 32.Z2030.00, 32.Z2032.00, 32.Z2034.00, 32.Z2036.00, 32.Z2038.00, 32.Z2040.00, 72.T1950.00, 72.T1951.00, 72.T1952.00, 72.T1953.00
FDA Enforcement
Class II
·Terminated·Omnia SRL·May 5, 2021
ENERPEEL GA-40
Basic UDI-DI
EU MDD
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Eu Md Class 2a
·GENERAL TOPICS SRL·1 device
ab medica spa
Importer
🇮🇹 Italy·10 Manufacturers
MDR 00001-A
Certificate
MDR QMS·Ascom UMS Srl·KIWA CERMET ITALIA S.P.A.
MDR 00001-A
Certificate
MDR QMS·Ascom UMS Srl·KIWA CERMET ITALIA S.P.A.