Facility

NAKANISHI INC.

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

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3002807687
Establishment type	Manufacture Medical Device
Location	700 SHIMOHINATA Kanuma Tochigi, JP 32286
Registration status	Active · expires 2026
Parent company	NAKANISHI INC. (owner-operator 8030216)
Brand names	Surgic XT Plus 120V LED; SG50MS Motor; Surgic AP S 120; Surgic XT Plus 120V OPT; SGL50M Motor; SG50M; Surgic AP(120V); Surgic XT Plus 120V N-OPT; Surgic XTSTT120MS w/o HP; SG50MS; Surgic XTS120; Surgic XT12 w/o HP

Activity by year

Recalls (2)

Devices registered here (1)

Controller, Foot, Handpiece And Cord
Product code EBW (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…

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. “NAKANISHI INC. (FEI 3002807687) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807687-nakanishi-inc/

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