Home › Device types › LBH
Varnish, Cavity
FDA product code LBH · Class 2 · Dental
998
Registered devices
217
Adverse events
9
Recalls
138
510(k) clearances
Devices with this code
D-LISH — YOUNG DENTAL MANUFACTURING I, LLCVOCO Profluorid Varnish — VOCO GmbHProfisil — Kettenbach GmbH & Co. KGSurgiMac — Surgimac LLCVELLAmini 5% Sodium Fluoride Varnish Caramel Box 100 — PreventechZooby — YOUNG DENTAL MANUFACTURING I, LLCMARK3 — CARGUS INTERNATIONAL, INCKOLORZ — DMG AMERICA, LLCWaterpik UltraClear Fluoride Varnish (Strawberry) — WATER PIK, INC.SciPharm Copal Cavity Varnish — SCIENTIFIC PHARMACEUTICALS, INC.Durashield® CV — Sultan Healthcare IncFluoriMax 2.5% NaF demo pack — ELEVATE ORAL CARE, LLCCrosstex International — CROSSTEX INTERNATIONAL, INC.VarnishAmerica — MEDICAL PRODUCTS LABORATORIES, INC.Varnish Pen - Mint — YOUNG DENTAL MANUFACTURING I, LLCFluoriMax 2.5% NaF Varnish 1 Bottle Kit Unflavored — ELEVATE ORAL CARE, LLCVOCO Profluorid Varnish — VOCO GmbHVarnal — CETYLITE INDUSTRIES INCWONDERFUL 5% NAF VARNISH WHITE CHOCOLATE SINGLES — YOUNG DENTAL MANUFACTURING I, LLCNanodent — PHOENIX DENTAL, INC.Sparkle V Sodium Fluoride Varnish, Cherry — CROSSTEX INTERNATIONAL, INC.Varnish America 0.25ml Box / 200 Raspberry — YOUNG DENTAL MANUFACTURING I, LLC5% Clear Sodium Fluoride Varnish Melon 500ct — DARBY DENTAL SUPPLY, LLCIpana 5% Sodium Fluoride Varnish - Caramel — MAXILL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-21 | Keystone Industries | A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526). |
| 2023-05-23 | Young Dental Manufacturing I, LLC | The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. |
| 2019-10-30 | Young Dental Manufacturing Co, LLC | Product shelf life may be shorter than that indicated on the label. |
| 2018-07-12 | Ultradent Products, Inc. | Dental varnish has the possibility of having an unpleasant and off flavor. |
| 2018-07-06 | 3M Company - Health Care Business | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. |
| 2014-10-24 | Discus Dental LLC | Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6% concentration as dispensed) on one side of the dual ba |
| 2014-09-29 | Dharma Research, Inc. | During an FDA inspection, it was found that the products are being marketed without a cleared 510k. |
| 2014-09-29 | Dharma Research, Inc. | During an FDA inspection it was found that the products are marketed without a cleared 510k. |
| 2014-04-23 | Heraeus Kulzer, LLC. | The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude |
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