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Cytoplast Resorb (R-250 +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993610

by Osteogenics Biomedical, Inc.

Identifiers

510(k) Number
K993610 FDA 510(k)
FDA Product Code
LYC FDA 510(k)
Models / Variants
R-250 FDA 510(k)
Rp-250 FDA 510(k)
Ru-250 FDA 510(k)
Rps-250 FDA 510(k)
Rpl-250 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)

Cytoplast Resorb (R-250 +4 more) by Osteogenics Biomedical, Inc. — 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

Sources (1)

  • FDA 510(k) K993610 24 fields · synced Jun 18, 2026