K250267

Substantially Equivalent

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)

Applicant: Kettenbach GmbH & Co. KG
Product code: EBF
Advisory panel: Dental
Date received: 2025-01-30
Decision date: 2025-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eschenburg, DE

Download summary PDF View on FDA.gov ↗

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