Identity
- Trade Name
- Waterlase MDX 450 Laser System EUDAMEDWaterlase MDX 300 Laser System FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- Waterlase MDX 450 EUDAMEDAn all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
- Model / Reference
- 7200860-06 EUDAMED7200861-06 FDA UDI
- Description
- An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use. FDA UDI
Identifiers
- Catalog Number
- 7200861-06 FDA UDI
- Primary DI / UDI-DI
- 00647529000298 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529000298 EUDAMED
- 510(k) Number
- K101658 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011014 ERBIUM SURGICAL LASER EUDAMED
- GMDN Term
- Dental solid-state 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
No
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
Waterlase MDX 450 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-00647529000298 | 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 d5923335-443d-4593-8371-91bdd6c8e352 61 fields · synced Aug 2, 2026
- FDA UDI 764b4a3d-e929-4d86-afe8-cf3be23e2b08 37 fields · synced May 30, 2026