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Colgate Profesional Sensitivity Relief Serum Tube

COLGATE ORAL PHARMACEUTICALS, INC. · Model US06793A · UDI-DI 00035000977786

LBH Prescription

510(k) clearances

218

Adverse events

Recalls

Facilities

Description

Colgate Profesional Sensitivity Relief Serum is designed to provide rapid sensitivity relief from painful sensitivity of teeth to cold, heat, acids, sweets, or contact. The product is directly applied to any sensitive teeth with the fingertip and gently massaged for 1 minute. Pea-sized amount should be used on each direct application and repeated as needed on daily basis

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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Data 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.