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Hawk Intraoral Camera And Accessories

FDA 510(k)

Class I (US FDA 510(k))

510(k) K040116

by Dxm Co., Ltd

Identifiers

510(k) Number
K040116 FDA 510(k)
FDA Product Code
EIA FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 872.6640 FDA 510(k)
Regulation Number
872.6640 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Hawk Intraoral Camera And Accessories by Dxm Co., Ltd — Class I — 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) K040116 24 fields · synced Jun 18, 2026