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S575 Intraoral Docking Dental Camera

FDA 510(k)

Class I (US FDA 510(k))

510(k) K990948

by Sopro

Identifiers

510(k) Number
K990948 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)

S575 Intraoral Docking Dental Camera by Sopro — 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
Sopro

Sources (1)

  • FDA 510(k) K990948 24 fields · synced Jun 19, 2026