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D1 Led Curing Light, Spec 3, Dentronix Led 3000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121093

by Dxm Co., Ltd

Identifiers

510(k) Number
K121093 FDA 510(k)
FDA Product Code
EBZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.6070 FDA 510(k)
Regulation Number
872.6070 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

D1 Led Curing Light, Spec 3, Dentronix Led 3000 by Dxm Co., Ltd — 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
Dxm Co., Ltd
FDA Applicant
Dxm Co., Ltd.

Sources (1)

  • FDA 510(k) K121093 24 fields · synced Jun 18, 2026