CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE— 510(k) K946307

Name: FDA 510(k) clearance K946307
Creator: U.S. Food and Drug Administration
Published: 1995-01-26

Substantially Equivalent

Confi-Dental Products Co.

FDA 510(k) clearance K946307 for CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE, Substantially Equivalent on 1995-01-26. Applicant: Confi-Dental Products Co.. Device class: 2.

Clearance details

Applicant: Confi-Dental Products Co.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1994-12-28
Decision date: 1995-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

view all

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 Confi-Dental Products Co.

view all

K030807 — CARIES INDICATOR2003-06-09
K030743 — ETCHANT 40%2003-05-09
K955328 — CONFI-BOND1996-03-28
K955329 — RESILIENCE M5 PROTECTION PLUS1996-03-28
K954988 — CRYSTALLESSENCE1996-03-08

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