SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT— 510(k) K931857

Name: FDA 510(k) clearance K931857
Creator: U.S. Food and Drug Administration
Published: 1993-07-22

Substantially Equivalent

Confi-Dental Products Co.

FDA 510(k) clearance K931857 for SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT, Substantially Equivalent on 1993-07-22. Applicant: Confi-Dental Products Co.. Device class: 2.

Clearance details

Applicant: Confi-Dental Products Co.
Product code: Code EBC
Device class: Class 2
Regulation: 21 CFR 872.3765
Advisory panel: Dental
Date received: 1993-04-13
Decision date: 1993-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBC

view all

K260819 — Any-Com Seal2026-05-01
K243254 — Parkell Pit and Fissure Sealant2025-08-08
K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio2023-08-18
K230455 — Enamel Coating Resin2023-07-25
K190998 — BA Pit & Fissure Sealant2019-11-08

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.