FDA-Device2019-05-29Class II
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
Thommen Medical AG
Hazard
Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
Sold states
US Nationwide distribution in the state of OH.
Affected count
15 US
Manufactured in
Eschenweg 3, N/A, Bettlach, N/A, Switzerland
Products
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1390-2019Don't want to check this manually?
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