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laserwhite20 Whitening Gel
Biolase, Inc. · Model laserwhite20 · UDI-DI 00647529000113
LBH
Prescription
10
510(k) clearances
218
Adverse events
9
Recalls
93
Facilities
Description
laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.
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 barrel syringe instead |
| 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 on the desired area |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.