FDA-Device2025-04-23Class II
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Straumann USA LLC
Hazard
The devices are missing the laser marked depth markings.
Sold states
Worldwide - US Nationwide distribution in the states of CA, IN, ME, MN and the countries of Belgium, Finland, France, Germany, Iceland, Israel, Italy, Latvia, Malta, Romania, Switzerland, Ukraine, United Kingdom.
Affected count
45 units
Manufactured in
60 Minuteman Rd, Andover, MA, United States
Products
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1561-2025Don't want to check this manually?
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