NLZ
The FDA filing identifies the NLZ Built-In Motor System and lists several configurations, including NLZ PRO and Multi Pad 2 SET. It describes a dental treatment system integrated with a…
The FDA filing identifies the NLZ Built-In Motor System and lists several configurations, including NLZ PRO and Multi Pad 2 SET. It describes a dental treatment system integrated with a dental chair unit.
The system combines a motor system and Multi-Pad with an optional handpiece and cord. Its control unit operates as an electric micromotor, while the chair unit foot pedal controls motor speed.
System Operation
The filing says the system can connect to existing dental units to add a brushless electric micromotor with LED light. Software controls functions such as brightness, rotation direction, speed, and torque.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
Record
| Listed by | Nakanishi Inc., Japan |
|---|---|
| FDA product code | EBW |
| Device type | Controller, Foot, Handpiece And Cord |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K233288 |
| Record published | 2020-07-07 |
| Record revised | 2025-10-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NLZ | In distribution | |
| NLZ ADP | In distribution | |
| NLZ CDE | In distribution | |
| NLZ MOTOR&CORD | In distribution | |
| NLZ BF SET | In distribution | |
| NLZ CD | In distribution | |
| NLZ S120 | In distribution | |
| NLZ SEL | In distribution | |
| NLZ E U | In distribution | |
| NLZ PRO | In distribution | |
| NLZ E S120 | In distribution | |
| NLZ CDL | In distribution | |
| NLZ CDB | In distribution | |
| NLZ BF | In distribution | |
| NLZ U | In distribution | |
| NLZ SEL SET | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A-dec | A-dec, Inc. | 43 |
| X-Cube | Saeshin Precision Co., Ltd. | 22 |
| Maxso | Beyes Dental Canada, Inc. | 20 |
| Surgic Pro | Nakanishi Inc. | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 13 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 11 |
| woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 10 |
| NL400 | Nakanishi Inc. | 9 |
| NLX | Nakanishi Inc. | 9 |
| Surgic XT Plus | Nakanishi Inc. | 6 |
| Axiom® | Etablissements Anthogyr | 6 |
| StarDental Instrument Solutions | Dentalez, Inc. | 5 |
Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233288 | 2024-06-24 |
| K233117 | 2024-06-20 |
| K173905 | 2018-06-19 |
| K163402 | 2017-08-31 |
| K163131 | 2017-05-11 |
| K020327 | 2002-04-08 |
| K011926 | 2001-09-11 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.