Identity
- Trade Name
- Laser Handpiece EUDAMEDWaterlase Express Handpiece FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- Express Handpiece EUDAMEDA reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue procedures. FDA UDI
- Model / Reference
- 7220001 EUDAMEDFDA UDI
- Description
- A reusable handpiece intended for use with the Waterlase Express Laser System in a variety of dental hard-tissue and soft-tissue procedures. FDA UDI
Identifiers
- Catalog Number
- 7220001 FDA UDI
- Primary DI / UDI-DI
- 00647529002315 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529002315 EUDAMED
- 510(k) Number
- K161669 FDA UDI
- FDA Product Code
- GEX FDA UDI
- EMDN Code
- Z12011099 LASER SURGERY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Dental solid-state 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
No
FDA UDI
Serial Number
Yes
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-00647529002315 | 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 094e3ff1-4b6e-4a0f-859b-de26018d94e8 61 fields · synced Jun 19, 2026
- FDA UDI e827c209-d647-4de2-87f4-b504bf13ed93 36 fields · synced May 30, 2026