ZIRKONDENT— 510(k) K080146

Substantially Equivalent

Ergometa

FDA 510(k) clearance K080146 for ZIRKONDENT, Substantially Equivalent on 2008-06-06. Applicant: Ergometa. Device class: 2.

Clearance details

Applicant: Ergometa
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2008-01-22
Decision date: 2008-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aliso Viejo, CA, US

Download summary PDF View on FDA.gov ↗

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K260918 — Zolid Lunaris2026-06-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.