CHALLENGER DIRECT COMPOSITE— 510(k) K010219

Name: FDA 510(k) clearance K010219
Creator: U.S. Food and Drug Administration
Published: 2001-02-21

Substantially Equivalent

International Dental Research

FDA 510(k) clearance K010219 for CHALLENGER DIRECT COMPOSITE, Substantially Equivalent on 2001-02-21. Applicant: International Dental Research. Device class: 2.

Clearance details

Applicant: International Dental Research
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2001-01-24
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Ayer, MA, US

Download summary PDF View on FDA.gov ↗

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K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

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