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Mk-Dent High Speed Dental Handpiece (Hs 4021k +5 more)

FDA 510(k)

Class I (US FDA 510(k))

510(k) K032234

by MK-Dent GmbH

Identifiers

510(k) Number
K032234 FDA 510(k)
FDA Product Code
EFB FDA 510(k)
Models / Variants
Hs 4021k FDA 510(k)
4011k FDA 510(k)
4012k FDA 510(k)
Hs 6021k FDA 510(k)
6011k FDA 510(k)
6012k FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 872.4200 FDA 510(k)
Regulation Number
872.4200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Mk-Dent High Speed Dental Handpiece (Hs 4021k +5 more) by MK-Dent GmbH — Class I — FDA_510K — listed in FDA 510(k) — 6 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
MK-Dent GmbH

Sources (1)

  • FDA 510(k) K032234 24 fields · synced Jun 18, 2026