Identity
- Trade Name
- Laser Handpiece EUDAMEDDiode Laser System Surgical Handpiece FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Surgical Handpiece, 1Pk EUDAMEDA reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical soft tissue applications. FDA UDI
- Model / Reference
- 6400105 EUDAMEDFDA UDI
- Description
- A reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical soft tissue applications. FDA UDI
Identifiers
- Catalog Number
- 6400105 FDA UDI
- Primary DI / UDI-DI
- 00647529000151 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529000151 EUDAMED
- 510(k) Number
- K121286 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Laser Handpiece by Biolase Mg Llc — Class I — 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-00647529000151 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 7e9d6ffb-d886-45af-a1b8-a88543278469 61 fields · synced Jun 19, 2026
- FDA UDI 17839cbd-a1b5-4d25-92fc-6d95723d7f5d 36 fields · synced May 25, 2026