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Sign in to claim this brandNAKANISHI INC.
Japan·JP-MF-000011271
Last updated September 17, 2026
What NAKANISHI INC. makes
Nakanishi Inc. manufactures single-use orthopaedic burs, motorized dental handpieces (electric and pneumatic), and ultrasonic dental tips for scaling, debridement, and endodontic procedures. The portfolio also includes burring power tool attachments and line-powered surgical control units for power tools.
The company’s devices are classified as Class I, Class II, and Class IIa under global regulations, with listings in the EU’s eudamed registry and the FDA’s UDI system. The manufacturer is based in Japan.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Nakanishi Inc. manufacture?
Nakanishi Inc. specializes in dental and orthopaedic power tools and accessories. Their portfolio includes single-use orthopaedic burs, motorized dental handpieces (both electric and pneumatic), ultrasonic dental tips for scaling, debridement, and endodontic procedures, as well as burring power tool attachments and line-powered surgical control units. These devices are designed for precision surgical applications in dental and orthopaedic fields.
Where is Nakanishi Inc. based, and how does that affect their device regulations?
Nakanishi Inc. is based in Japan. While the company’s location influences its regulatory framework—such as adherence to Japanese standards and potential compliance with ISO or other global guidelines—the classification and authorization of individual devices (Class I, Class II, or Class IIa) are determined by the jurisdiction where they are marketed, not the manufacturer’s country. For example, their devices appear in the EU’s eudamed registry and the FDA’s UDI system, indicating compliance with those regions’ requirements.
Which regulatory registries list Nakanishi Inc.’s devices, and why are these important?
Nakanishi Inc.’s devices are listed in the EU’s eudamed registry and the FDA’s UDI (Unique Device Identifier) system. These registries are critical because they ensure traceability, transparency, and compliance with global medical device regulations. Listing in eudamed confirms the device meets EU requirements for market placement, while FDA UDI registration supports post-market surveillance and recall tracking in the U.S. Both registries help healthcare providers and regulators verify device authenticity and compliance.
How are Nakanishi Inc.’s devices classified under global regulations?
Nakanishi Inc.’s devices are classified as Class I, Class II, or Class IIa depending on their risk level and intended use. Class I devices pose the lowest risk (e.g., some single-use orthopaedic burs) and typically require general safety controls. Class II and Class IIa devices (such as motorized handpieces or ultrasonic tips) involve higher risks—like patient contact or complex functions—and require additional validation, such as clinical performance data or specialized testing, to ensure safety and effectiveness before authorization.
Why do some of Nakanishi Inc.’s devices appear in both eudamed and FDA UDI, while others might not?
A device’s presence in eudamed or the FDA UDI system depends on whether it is marketed in the EU or the U.S. Nakanishi Inc. likely manufactures devices intended for both regions, but only those explicitly sold or authorized in the EU are listed in eudamed, while those sold in the U.S. appear in the FDA UDI. If a device is not marketed in a specific region, it won’t be registered there—regulatory listings are tied to commercial availability, not the manufacturer’s global portfolio.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Japan
- Address
- 700, Shimohinata, Kanuma, Tochigi, Japan
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- JP-MF-000011271
- FDA FEI Number
- 3002807687
- DUNS Number
- 690710546
Catalogue (1807)
Page 32 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| E-Type Contra Angle Sheath | EC | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-2CDMS-50 | FDA UDI | Class II | Active |
| ER16i | ER16i | FDA UDI | Class II | Unknown |
| Micro Surgery Handpiece | SGS-E2S | FDA UDI | Class II | Unknown |
| NSK Sterile Burs/Drills | PDS-2RFUL-20 | FDA UDI | Class I | Active |
| Sgt-1 | SGT-1 | FDA UDI | Class II | Unknown |
| Endo-Mate Tc2 | ENDO-MATE TC2 Motor | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-1RCD110-30 | FDA UDI | Class I | Active |
| Z45l | Z45L | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-3NM-30 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-1C175-40 | FDA UDI | Class II | Active |
| S-Max pico BLED | S-Max pico BLED | FDA UDI | Class I | Unknown |
| Perio Kit A | Perio Kit A | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2DS-60 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2LES-11 | FDA UDI | Class II | Active |
| Ptl-Ms03 | PTL-MS03 | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-2DMS-60 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2DS-06 | FDA UDI | Class II | Active |
| M800 | M800 | FDA UDI | Class I | Active |
| Z900kl | Z900KL | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-3NCBM-18 | FDA UDI | Class II | Unknown |
| NSK Sterile Burs/Drills | PDS-2RDUL-30 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2CDS-20E | FDA UDI | Class II | Active |
| S-Max M Contra/Hp | M25 | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-3NS-22 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2AMS-75 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2CDL-50 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-1ND155-20 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2NCBES-18 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2FES-12 | FDA UDI | Class II | Active |
| Mp-F16r | MP-F16R | FDA UDI | Class I | Active |
| Handpiece Stand | Handpiece Stand | FDA UDI | Class I | Active |
| P300-2a10 | P300-2A10 | FDA UDI | Class II | Active |
| NSK Sterile Blades | PDS-RE-6127 | FDA UDI | Class II | Active |
| E20ri | E20RI | FDA UDI | Class II | Unknown |
| NSK Sterile Burs/Drills | PDS-2CBS-60 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2CDS-50 | FDA UDI | Class II | Active |
| Vs-Led-Hpsc | VS-LED-HPSC | FDA UDI | Class II | Unknown |
| Pro As-Pax Su B2 Kit | PRO AS-PAX SU B2 KIT | FDA UDI | Class II | Unknown |
| Z890kl | Z890KL | FDA UDI | Class I | Active |
| Nac-03 | NAC-03 | FDA UDI | Class I | Active |
| NE233 Charger | NE233 Charger | FDA UDI | Class I | Active |
| NSK Sterile Burs/Drills | PDS-3DM-70 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2NS-18 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-2RDUL-40 | FDA UDI | Class II | Active |
| NSK Sterile Burs/Drills | PDS-1MHCD110-40 | FDA UDI | Class I | Active |
| Npb-Ptl | NPB-PTL | FDA UDI | Class I | Unknown |
| Ti-Max X Contra/Hp | X12L | FDA UDI | Class I | Unknown |
| Ca13140001 | CA13140001 | EUDAMED | Class IIa | Active |
| C1062 | C1062 | EUDAMED | Class IIa | Active |
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