Identity
- Trade Name
- Epic Pro Diode Laser System EUDAMEDFDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Epic Pro Diode Laser System EUDAMEDA 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
- Model / Reference
- 7410004 EUDAMEDFDA UDI
- Description
- A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Identifiers
- Catalog Number
- 7410004 FDA UDI
- Primary DI / UDI-DI
- 00647529003541 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529003541 EUDAMED
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011016 DIODE SURGICAL LASER EUDAMED
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Epic Pro Diode Laser System by Biolase Mg Llc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00647529003541 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Biolase Mg Llc
- EUDAMED SRN
- US-MF-000028587
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (2)
- EUDAMED 10cd352a-1f2d-494c-b419-7c784ed86f6f 61 fields · synced Jun 1, 2026
- FDA UDI 063da292-b684-4d92-97c8-f871434726cb 35 fields · synced May 30, 2026