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Z-Look3 Evo Slm

FDA 510(k)

Class II (US FDA 510(k))

510(k) K120793

by Z-Systems AG

Identifiers

510(k) Number
K120793 FDA 510(k)
FDA Product Code
DZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3640 FDA 510(k)
Regulation Number
872.3640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Z-Look3 Evo Slm by Z-Systems AG — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Z-Systems AG

Sources (1)

  • FDA 510(k) K120793 24 fields · synced Jun 18, 2026