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Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171643

by Geistlich Pharma AG

Identifiers

510(k) Number
K171643 FDA 510(k)
FDA Product Code
NPL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3930 FDA 510(k)
Regulation Number
872.3930 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed by Geistlich Pharma AG — Class II — 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
Geistlich Pharma AG

Sources (1)

  • FDA 510(k) K171643 24 fields · synced Jun 18, 2026