Flexitime Monophase Pro Scan

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K113574 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K042878 Active Cleared 17 Dec 2004

• Venus Diamond Flow

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See all devices from Heraeus Kulzer, Inc. →