← Back to catalogue
Diode Laser Tips - Non Initiated Tips
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7410003Ref 7400021Ref 7400057Ref 7400015Ref 7400016Ref 7400018Ref 7400058Ref 6400604
Identity
- Trade Name
- Diode Laser Tips - Non Initiated Tips EUDAMEDDiode Laser Tips FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Diode Laser Tips, Perio EZ Tips, 30Pk EUDAMEDDiode Laser Tips ezTips, Endo, E2-14, 30PK EUDAMEDDiode Laser Tips, ezTips, Surgical, E4-100, 5PK EUDAMEDDiode Laser Tips, ezTips, Endo, E2-20, 20PK EUDAMEDDiode Laser Tips, ezTips, Surgical, E4-4, 30PK EUDAMEDDiode Laser Tips, ezTips, Surgical, E2-4, 30PK EUDAMEDDiode Laser Tips, ezTips, Surgical, E4-250, 1PK EUDAMEDDiode Laser Tips, EZ Tips, Starter Kit, 10Pk EUDAMEDA tip kit containing 10 single-use, non-initiated laser tips intended for use with Biolase diode laser delivery systems. The tips have the same length of 4mm and vary in core diameter. FDA UDI
- Model / Reference
- 7410003 EUDAMED7400021 EUDAMED7400057 EUDAMED7400015 EUDAMED7400016 EUDAMED7400018 EUDAMED7400058 EUDAMED6400604 EUDAMEDEZ Tips, Starter Kit FDA UDI
- Description
- A tip kit containing 10 single-use, non-initiated laser tips intended for use with Biolase diode laser delivery systems. The tips have the same length of 4mm and vary in core diameter. FDA UDI
Identifiers
- Catalog Number
- 6400604 FDA UDI
- Primary DI / UDI-DI
- 00647529002650 EUDAMED00647529001837 EUDAMED00647529001875 EUDAMED00647529001776 EUDAMED00647529001783 EUDAMED00647529001806 EUDAMED00647529001882 EUDAMED00647529003237 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529002650 EUDAMEDB-00647529001837 EUDAMEDB-00647529001875 EUDAMEDB-00647529001776 EUDAMEDB-00647529001783 EUDAMEDB-00647529001806 EUDAMEDB-00647529001882 EUDAMEDB-00647529003237 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 IIa 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
Yes
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
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
Dimensions & Sizes
- Size
- Outer Diameter — 400 Micrometer FDA UDIOuter Diameter — 300 Micrometer FDA UDILength — 4 Millimeter FDA UDI
Diode Laser Tips - Non Initiated Tips by Biolase Mg Llc — Class IIa — 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-00647529002650 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolase Mg Llc
- EUDAMED SRN
- US-MF-000028587
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (9)
- EUDAMED 18ca7b84-dc53-4e47-ba7f-869899c58633 61 fields · synced Aug 4, 2026
- EUDAMED 60a596b3-cda9-4562-9e49-758c0dab3971 61 fields · synced May 17, 2026
- EUDAMED 2089e2a0-658e-45c7-b6b4-ccbd39be344d 61 fields · synced May 17, 2026
- EUDAMED 4550fec0-236a-4851-b79e-1e34a5b5c5c3 61 fields · synced May 18, 2026
- EUDAMED 7a86f300-b8c0-4377-9660-8550252c1e83 61 fields · synced May 18, 2026
- EUDAMED bafeb6cc-f3a1-4423-9c48-0b71b3571c72 61 fields · synced May 18, 2026
- EUDAMED 222c1964-5e04-48bb-87a4-9d38673d466c 61 fields · synced May 18, 2026
- EUDAMED 945c8a53-3267-43ed-9bee-2c8b357b8330 61 fields · synced May 19, 2026
- FDA UDI 6cbb7f7a-3f9a-41e9-857d-de7152abfa00 37 fields · synced May 30, 2026