Device recall

Z-0425-2015: Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity…

FDA device recall · Class II · Discus Dental LLC

Key facts

Recall number (Z-number) Z-0425-2015
Recall event 69625
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
Product code LBH
Recalling firm Discus Dental LLC
Recall class Class II
Status Terminated
Termination date Apr 14, 2015
510(k) numbers K062176
FEI number 1000582314

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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