FDA UDI
In Commercial Distribution
🇺🇸 United States
Primo Dental Laser
DI: 08059340290024
·
Model: Primo Komfort
·
MEDENCY SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Primo Dental Laser
- Primary DI
- 08059340290024
- Version / Model
- Primo Komfort
- Catalog Number
- MD.PRIMO.D.01.03.DEN
- Company Name
- MEDENCY SRL
- Labeler DUNS
- 436042800
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-10
- Public Version
- 2
- Public Version Date
- 2025-05-22
- Public Version Status
- Update
- Public Device Record Key
- df870cf0-9eda-4956-9c57-c2de8022a7c1
Device Description
Max power: 7W Wavelength: 810nm The model Primo Komfort of the family of medical devices "Primo Dental Laser" is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NVK | Laser, Dental, Soft Tissue | General, Plastic Surgery | 878.4810 | 2 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60341 | General/multiple surgical diode laser system | An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059340290024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232222 | 000 |