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Proglass Cements (one +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101869

by Silmet Ltd

Identifiers

510(k) Number
K101869 FDA 510(k)
FDA Product Code
EMA FDA 510(k)
Models / Variants
one FDA 510(k)
Two Two Lc FDA 510(k)
Nine FDA 510(k)
Plus FDA 510(k)
Silver FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3275 FDA 510(k)
Regulation Number
872.3275 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Proglass Cements (one +4 more) by Silmet Ltd — Class II — FDA_510K — listed in FDA 510(k) — 5 models — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Silmet Ltd
FDA Applicant
Silmet , Ltd.

Sources (1)

  • FDA 510(k) K101869 24 fields · synced Jun 19, 2026