AXCEL— 510(k) K051931

Substantially Equivalent

Tri Dental Innovators

FDA 510(k) clearance K051931 for AXCEL, Substantially Equivalent on 2006-02-17. Applicant: Tri Dental Innovators. Device class: 2.

Clearance details

Applicant: Tri Dental Innovators
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2005-07-13
Decision date: 2006-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Garden Grove, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Tri Dental Innovators

K063714 — AXCEL FLOW2007-01-31

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