Device recall

Z-0800-2007: 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade…

FDA device recall · Class II · 3M Espe Dental Products

Key facts

Recall number (Z-number) Z-0800-2007
Recall event 37635
Product 3M ESPE Rely X Veneer Cement Refill Syringes, A3 Opaque/Yellow Opaque Shade, manufactured by 3M. ESPE is a radiopaque , color stable light-cured resin cement indicated for bonding veneers fabricated of porcelainor composite.
Product code EBF
Recalling firm 3M Espe Dental Products
Recall class Class II
Status Terminated
Termination date Feb 24, 2008
510(k) numbers K991961
FEI number 2020493

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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

Browse all FDA device recalls (products)