DeviceClearance

Visalys® Bulk Fill 1 x 4 g Syringe (15060) +5 more— 510(k) K250267

Substantially Equivalent

Kettenbach GmbH & Co. KG

FDA 510(k) clearance K250267 for Visalys® Bulk Fill 1 x 4 g Syringe (15060) +5 more, Substantially Equivalent on 2025-03-14. Applicant: Kettenbach GmbH & Co. KG. Device class: 2.

Clearance details

Device name as filed
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
Code EBF
Device class
Class 2
Regulation
21 CFR 872.3690
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Eschenburg, DE
Download summary PDFView on FDA.gov ↗

Recent devices under product code EBF

view all

More clearances from Kettenbach GmbH & Co. KG

view all

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