RegWardenFDA facility compliance records
Facility

NSK AMERICA CORP.

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2018: 1 recalls1201620171201820192020202120222023202420252026
  • Recalls (2)

Devices registered here (1)

  • Handpiece, Contra- And Right-Angle Attachment, Dental
    Product code EGS (opens in a new tab) · Class I · Dental · 21 CFR 872.4200

Recalls & enforcement

  • Class IITerminated2018-06-01
    Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manual…
  • Class IITerminated2016-07-08
    Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to sin…

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. “NSK AMERICA CORP. (FEI 1000139790) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000139790-nsk-america-corp/

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