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510(k) K230333

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) by Kettenbach GmbH & Co. KG — Product Code LBH

K230333 is an FDA 510(k) premarket notification submitted by Kettenbach GmbH & Co. KG for the device "Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)". The FDA issued a decision of Substantially Equivalent on July 24, 2023. The device falls under product code LBH (Varnish, Cavity), a Class II device regulated under 21 CFR 872.3260. Kettenbach GmbH & Co. KG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2023
Date Received
February 7, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

Other clearances by Kettenbach GmbH & Co. KG

  • K250267 — Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (March 14, 2025)
  • K191527 — Visalys CemCore, Visalys Cem Core Try In Paste (November 8, 2019)
  • K191523 — Visalys Restorative Primer (October 9, 2019)
  • K191524 — Visalys Tooth Primer (September 29, 2019)
  • K143104 — Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X (March 25, 2015)
  • K122039 — KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B (December 27, 2012)
  • K113279 — IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDEN (November 14, 2011)
  • K092867 — IDENTIUM HEAVY, MEDIUM, MEDIUM SOFT, LIGHT (October 1, 2009)
  • K083701 — PANASIL INITIAL CONTACT AND PANASIL TRAY (January 9, 2009)
  • K082560 — PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CON (September 8, 2008)

Other clearances for product code LBH

  • K253052 — Fluoride Varnish (Type A,Type C) (June 11, 2026)
  • K252073 — VOCO Profluorid Varnish + BioMin (May 1, 2026)
  • K261404 — UltraEZ (April 30, 2026)
  • K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) (March 18, 2026)
  • K250714 — FluoroDose Varnish (November 21, 2025)
  • K243777 — Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Var (May 27, 2025)
  • K241489 — ReminGel (January 8, 2025)
  • K241568 — CrystLCare™ PRO Biorestorative, Fluoride-Plus (January 2, 2025)
  • K242913 — Jasmate® Toothpaste (November 22, 2024)
  • K233768 — Papacarie Duo (July 18, 2024)

FDA data resources