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TSI - Eri

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090174

by Oco Biomedical

Identifiers

510(k) Number: K090174 FDA 510(k)
FDA Product Code: DZE FDA 510(k)
Models / Variants: Tsi FDA 510(k)
Eri FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.3640 FDA 510(k)
Regulation Number: 872.3640 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

TSI - Eri by Oco Biomedical — Class II — FDA_510K — listed in FDA 510(k) — 2 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer: Oco Biomedical

Sources (1)

FDA 510(k) K090174 24 fields · synced Jun 18, 2026