Recall Z-0425-2015— Discus Dental LLC
Class II · Terminated
Class II FDA medical device recall by Discus Dental LLC, initiated 2014-10-24, terminated 2015-04-14. It names one FDA 510(k) clearance: K062176. Product: Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits. Reason: 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 of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity..
- Recalling firm
- Discus Dental LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-24
- Terminated
- 2015-04-14
- Firm location
- Ontario, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Reason for recall
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 of the intended component (phosphate gel). Consequently, use of this product by patients may result in a neutral effect or increased sensitivity.
Data sourced from openFDA. This site is unofficial and independent of the FDA.