Device recall

Z-2674-2016: Diamond Coated Tips and Burs are accessories to the air powered dental handpiece…

FDA device recall · Class II · Nakanishi Inc.

Key facts

Recall number (Z-number) Z-2674-2016
Recall event 74666
Product Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material, reducing hard tooth…
Product code EFB
Recalling firm Nakanishi Inc.
Recall class Class II
Status Terminated
Termination date Jun 25, 2018
510(k) numbers K962543
FEI number 3002807687

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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