Nakanishi, Inc.
Nakanishi, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 11 FDA device recalls on record.
Top product codes for Nakanishi, Inc.
FDA recalls by Nakanishi, Inc.
10 most recent of 11- Z-0223-2019 — Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-0221-2019 — Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-0225-2019 — Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-0224-2019 — Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..
- Z-0219-2019 — Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-0226-2019 — Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-0222-2019 — Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-0220-2019 — Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.
- Z-2674-2016 — 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 structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
- Z-2672-2016 — Diamond Coated Tips and Burs are accessories to the Ultrasonic Scaler (VARIOS 350 LUX, VARIOS 350, VARIOS 150 LUX, VARIOS 150). The intended use of the tips is based on the parent device. For the ultrasonic scalers and the sonic air scaler, the tips are used for various actions such as scaling (removal of calculus), periodontics (root planing and maintenance), endodontics (root canal enlarging, irrigation, and filling), restorative (caries removal and tooth surface detailing).
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nakanishi, Inc.
- K260773 — Varios Combi Pro2
- K254163 — VarioSurg 4
- K251689 — VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) +2 more
- K252662 — UniBur
- K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
- K233288 — NLZ Built-In Motor System
- K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
- K233308 — Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)
- K230888 — Titanium Turbine
- K230106 — General Cutting Straight
- K222518 — FX Contra
- K203791 — Stainless Turbine
- K202120 — P300 Attachment
- K211584 — Oral Surgery Contra
- K202960 — General Cutting Contra Handpiece
- K182999 — General Cutting Contra Handpiece
- K173905 — Surgic Pro, Surgic Pro+
- K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece
- K163402 — NLZ Motor System
- K163483 — PANA SPRAY Plus
- K163131 — A-dec NLZ Electric Motor System
- K132264 — PRIMADO2 TOTAL SURGICAL SYSTEM
- K131578 — IPROPHY MOBILE
- K113717 — ULTRASONIC SCALER
- K121901 — TI-MAX Z45
- K113530 — ULTRASONIC SCALER
- K112024 — TI-MAX X450
- K113655 — TI-MAX X TURBINE
- K110278 — CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION SYSTEM, MODEL ISD900
- K112673 — PROPHY-MATE NEO
- K083112 — PRIMADO
- K081811 — CARE3 PLUS
- K080722 — PRIMADO SURGICAL DRILL
- K073678 — VARIOSURG
- K071447 — VARIOS 75
- K062731 — ULTRASONIC SCALER, VARIOS 560
- K031421 — ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT)
- K032395 — PROPHY-MATE
- K020327 — SURGIC IV IMPLANT CONTROL UNIT
- K011926 — ELEC-MATE E
Data sourced from openFDA. This site is unofficial and independent of the FDA.