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Vantage (V5000 +3 more) - V5000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122643

by Midmark Corp.

Identifiers

510(k) Number
K122643 FDA 510(k)
FDA Product Code
MUH FDA 510(k)
Models / Variants
V5000 FDA 510(k)
V5100 FDA 510(k)
V5000c FDA 510(k)
V5100c FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Vantage (V5000 +3 more) - V5000 by Midmark Corp. — Class II — FDA_510K — listed in FDA 510(k) — 4 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Midmark Corp.

Sources (1)

  • FDA 510(k) K122643 24 fields · synced Jun 18, 2026