| Primary Device ID | 06430035420322 |
| NIH Device Record Key | 902d09f3-62da-4b45-ae83-2a9b468c22e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Planmeca ProOne |
| Version Model Number | ProOne |
| Catalog Number | 10012010 |
| Company DUNS | 368788568 |
| Company Name | Planmeca Oy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06430035420322 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-10 |
| 06430035420599 - Planmeca Romexis | 2023-06-22 Planmeca Romexis is a modular imaging software for dental and medical use. |
| 06430035420612 - Planmeca Compact | 2019-11-06 Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped with a digital control system a |
| 06430035420605 - Planmeca Viso | 2019-03-14 The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillof |
| 06430035420575 - Planmeca Compact | 2019-02-04 Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equipped with a digital control sys |
| 06430035420551 - Planmeca Viso | 2018-10-22 The Planmeca Viso -X-ray unit uses cone beam computed tomography (CBCT) to produce three-dimensional (3D) images of the maxillof |
| 06430035420100 - Planmeca Sovereign | 2018-07-06 Planmeca Sovereign is a dental operative unit including a dental patient chair. The versatile swivelling enables fluent two-hand |
| 06430035420162 - Planmeca Chair | 2018-07-06 Planmeca Chair is electronically controlled patient chair with swivel funcion allowing the chair to be swivelled 90 degrees to l |
| 06430035420247 - Planmeca SingLED | 2018-07-06 Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology. |