FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmeca ProOne
DI: 06430035420322
·
Model: ProOne
·
Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca ProOne
- Primary DI
- 06430035420322
- Version / Model
- ProOne
- Catalog Number
- 30010469
- Company Name
- Planmeca Oy
- Labeler DUNS
- 368788568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-10
- Public Version
- 5
- Public Version Date
- 2021-04-21
- Public Version Status
- Update
- Public Device Record Key
- 902d09f3-62da-4b45-ae83-2a9b468c22e6
Device Description
Planmeca ProOne is a dental panoramic X-ray imaging system, which is intended for dental radiographic examination and diagnosis of teeth, jaw and oral structures.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUH | System,X-Ray,Extraoral Source,Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43369 | Stationary panoramic dental x-ray system, digital | A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035420322 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K072244 | 000 |