| Primary Device ID | 06944835130195 |
| NIH Device Record Key | ff26daf9-a271-4107-8132-2b65545d9f5f |
| Commercial Distribution Discontinuation | 2030-12-18 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIC/SUPERLINE |
| Version Model Number | Alpha Endo |
| Company DUNS | 527943851 |
| Company Name | Shenzhen Superline Technology Co., Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06944835130195 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06944835130195]
Moist Heat or Steam Sterilization
[06944835130195]
Moist Heat or Steam Sterilization
[06944835130195]
Moist Heat or Steam Sterilization
[06944835130195]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-30 |
| Device Publish Date | 2025-12-22 |
| 06944835130195 - NIC/SUPERLINE | 2025-12-30Alpha Endo Handpiece is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. |
| 06944835130195 - NIC/SUPERLINE | 2025-12-30 Alpha Endo Handpiece is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a |
| 06944835190281 - NIC or SUPERLINE | 2025-09-26 The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials duri |
| 06944835190373 - NIC or SUPERLINE | 2025-09-26 The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials duri |
| 06944835190427 - NIC or SUPERLINE | 2025-09-26 The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials duri |
| 06944835190502 - NIC or SUPERLINE | 2025-09-26 The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials duri |
| 06944835190588 - NIC or SUPERLINE | 2025-09-26 The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials duri |
| 06944835190823 - NIC or SUPERLINE | 2025-09-26 The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental materials duri |
| 06944835190014 - NIC or SUPERLINE | 2025-09-25 Intended use The product is used with dental motors, it is intended for cutting, trim and finish natural and engineered dental m |