FDA UDI
In Commercial Distribution
🇺🇸 United States
Planmeca Solanna
DI: 06430035420544
·
Model: Solanna
·
Planmeca Oy
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Planmeca Solanna
- Primary DI
- 06430035420544
- Version / Model
- Solanna
- Catalog Number
- 30006329; 30009016
- Company Name
- Planmeca Oy
- Labeler DUNS
- 368788568
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-03
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6ec15b9d-c7b7-4652-bdf0-04206ad43943
Device Description
The Planmeca Solanna operating light gives perfect visibility over the entire treatment area with adjustable brightness and colour temperature. The light head moves smoothly to cater the needs of users of all sizes, sitting or standing. The light head with 3-axis movement is easy and effortless to position. The exceptionally long arm enables optimal working conditions for operations of all kinds.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EAZ | Light, Operating, Dental | Dental | 872.4630 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 56320 | LED dental light, line-powered | A mains electricity (AC-powered) device designed for use in dentistry to project an intense focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED) situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit and a transformer that supplies mains, stepped-down, low-voltage electricity (e.g., 12 volt), via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06430035420544 | GS1 |