Home › Device types › LBH
Varnish, Cavity
FDA product code LBH · Class 2 · Dental
1,016
Registered devices
218
Adverse events
9
Recalls
139
510(k) clearances
Devices with this code
MEDICOM DURAFLOR — AMD Medicom IncNovaBright — NANOVA BIO MATERIALS INCFluorodose — CENTRIX, INC.MARK3 — CARGUS INTERNATIONAL, INCFluorilaq Salted Caramel (10mL) Tube — PASCAL COMPANY, INC.MEDICOM DURAFLOR — AMD Medicom IncEMBRACE VARNISH Sample — PULPDENT CORPORATIONCOPALITE — TEMREX CORPORATIONEnamelast — ULTRADENT PRODUCTS, INC.VarnishAmerica — MEDICAL PRODUCTS LABORATORIES, INC.Varnish, Bulk, Oral-B, Strawberry 1800 — YOUNG DENTAL MANUFACTURING I, LLCConsepsis — ULTRADENT PRODUCTS, INC.Consepsis — ULTRADENT PRODUCTS, INC.VarnishAmerica — MEDICAL PRODUCTS LABORATORIES, INC.Cervitec Plus — IVOCLAR VIVADENT AKTIENGESELLSCHAFTIRIS — BENCO DENTAL SUPPLY CO.RIVA STAR — SDI LIMITEDFluoriMax Cotton Candy — ELEVATE ORAL CARE, LLCKOLORZ — DMG AMERICA, LLCFast Release Varnish — 3M COMPANYPremier — PREMIER DENTAL PRODUCTS COMPANYEnamelast — ULTRADENT PRODUCTS, INC.Dental City — ICP, INC.Enamelast — ULTRADENT PRODUCTS, 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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