RegWardenFDA facility compliance records
Facility

COLTENE/WHALEDENT AG

8 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2018: 2 recalls; 2019: 1 recalls; 2020: 2 recalls; 2021: 1 recalls; 2023: 1 recalls1’13’14’15’16’172’181’192’201’21’221’23’24’25’26
  • Recalls (8)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2023-01-20
    Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
  • Class IIOngoing2021-03-18
    The incorrect dental pins were packaged and subsequently distributed.
  • Class IIOngoing2020-10-20
    The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
  • Class IIOngoing2020-06-03
    Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
  • Class IITerminated2019-07-19
    A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.
  • Class IITerminated2018-08-21
    ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
  • Class IITerminated2018-04-13
    The products are labeled with an incorrect product number.
  • Class IITerminated2013-12-11
    Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “COLTENE/WHALEDENT AG (FEI 3002806620) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002806620-coltene-whaledent-ag/

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