A-Dec
NLZ BA,Control Module/Tubing ASSY/Motor Kit,63 IN, OTC
4manufacturers in China registered for this device type
43catalogue numbers in this listing
2510(k) clearances naming this product code
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 | A-dec, Inc., United States |
|---|---|
| FDA product code | EBW |
| Device type | Controller, Foot, Handpiece And Cord |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K251811 |
| Record published | 2022-11-07 |
| Record revised | 2023-05-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54.0447.00 | In distribution | |
| 54.1052.00 | In distribution | |
| 54.1003.00 | In distribution | |
| 54.0846.00 | In distribution | |
| 54.0601.00 | In distribution | |
| 54.1004.00 | In distribution | |
| 54.1073.00 | In distribution | |
| 54.0790.00 | In distribution | |
| 54.0605.01 | In distribution | |
| 54.0798.01 | In distribution | |
| 54.0708.00 | In distribution | |
| 54.1076.00 | In distribution | |
| 54.0797.01 | In distribution | |
| 54.0446.01 | In distribution | |
| 54.0438.00 | In distribution | |
| 54.1074.00 | In distribution | |
| 54.0602.00 | In distribution | |
| 54.0809.01 | In distribution | |
| 54.0439.00 | In distribution | |
| 54.0852.00 | In distribution | |
| 54.0726.00 | In distribution | |
| 54.0796.01 | In distribution | |
| 54.0807.01 | In distribution | |
| 54.1074.01 | In distribution | |
| 54.0446.00 | In distribution | |
| 54.0727.00 | In distribution | |
| 54.0606.01 | In distribution | |
| 54.0808.01 | In distribution | |
| 54.0726.01 | In distribution | |
| 54.0437.00 | In distribution | |
| 54.0606.00 | In distribution | |
| 54.1051.00 | In distribution | |
| 54.0854.00 | In distribution | |
| 54.1073.01 | In distribution | |
| 54.0853.01 | In distribution | |
| 54.1005.00 | In distribution | |
| 54.0847.01 | In distribution | |
| 54.0847.00 | In distribution | |
| 54.0605.00 | In distribution | |
| 54.0852.01 | In distribution | |
| 54.0846.01 | In distribution | |
| 54.0854.01 | In distribution | |
| 54.0727.01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X-Cube | Saeshin Precision Co., Ltd. | 22 |
| Maxso | Beyes Dental Canada, Inc. | 20 |
| NLZ | Nakanishi Inc. | 16 |
| 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 |
|---|---|
| K133776 | 2014-05-28 |
| K032572 | 2003-12-03 |
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.