FDA UDI
In Commercial Distribution
🇺🇸 United States
EdgePro
DI: 00647529004241
·
Model: EdgePro Handpiece
·
Biolase, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EdgePro
- Primary DI
- 00647529004241
- Version / Model
- EdgePro Handpiece
- Catalog Number
- 7220007
- Company Name
- Biolase, Inc.
- Labeler DUNS
- 152165700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 1
- Public Version Date
- 2023-06-27
- Public Version Status
- New
- Public Device Record Key
- 076324bc-07c1-4f50-af58-e71b40b0c651
Device Description
A reusable handpiece intended for use with the EdgePro Laser System (Juno) in a variety of dental hard-tissue and soft-tissue procedures.
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47880 | Dental solid-state laser system | A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for application in dental procedures; it does not include frequency-doubling technology. It typically includes a light source, delivery/positioning device(s), controls/foot-switch. It is intended to incise, excise, vaporize, ablate, and coagulate oral soft tissue; and cut, shave, contour, and resect oral bone/teeth. Its high-water affinity and high-fluency pulses produce an exceptionally narrow zone of damage around the soft-tissue vaporization crater. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00647529004241 | GS1 |
Customer Contacts
- Phone
- 1-800-321-6717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213428 | 000 |