VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL— 510(k) K140350

Name: FDA 510(k) clearance K140350
Creator: U.S. Food and Drug Administration
Published: 2014-12-12

Substantially Equivalent

Preventive Technologies, Inc.

FDA 510(k) clearance K140350 for VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL, Substantially Equivalent on 2014-12-12. Applicant: Preventive Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Preventive Technologies, Inc.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2014-02-11
Decision date: 2014-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indian Trail, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBH

view all

K262243 — Profisil Free2026-09-03
K253052 — Fluoride Varnish (Type A,Type C)2026-06-11
K252073 — VOCO Profluorid Varnish + BioMin2026-05-01
K261404 — UltraEZ2026-04-30
K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)2026-03-18

More clearances from Preventive Technologies, Inc.

view all

K100539 — PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE2010-06-17
K951016 — DISPOSABLE PROPHYLAXIS ANGLE1995-05-02

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