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Diode Laser Tips - Pre Initiated Tips
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 7430002Ref 7400069Ref 7400068Ref 7400071Ref 6400605Ref 7400065
Identity
- Trade Name
- Diode Laser Tips - Pre Initiated Tips EUDAMEDDiode Laser Tips FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- Diode Laser Tips,PI Pro Tips, Surgical, 4-4, 20PK EUDAMEDDiode Laser Tips, pre-initiated, Perio, 4-9, 30PK EUDAMEDDiode Laser Tips, pre-initiated, Perio, 4-7,30PK EUDAMEDDiode Laser Tips, pre-initiated, Surgical, 3-4, 30PK EUDAMEDDiode Laser Tips, PI Pro Tips Starter Kit, 10PK EUDAMEDDiode Laser Tips, pre-initiated, Perio, 3-9, 30PK EUDAMEDA starter kit containing 10 single-use pre-initiated laser tips intended for use with Epic Pro Diode Laser Systems. The tips have the same length of 4 mm and core diameters of 300 and 400 µm. FDA UDI
- Model / Reference
- 7430002 EUDAMED7400069 EUDAMED7400068 EUDAMED7400071 EUDAMED6400605 EUDAMED7400065 EUDAMEDPI Pro Tips, Starter Kit FDA UDI
- Description
- A starter kit containing 10 single-use pre-initiated laser tips intended for use with Epic Pro Diode Laser Systems. The tips have the same length of 4 mm and core diameters of 300 and 400 µm. FDA UDI
Identifiers
- Catalog Number
- 6400605 FDA UDI
- Primary DI / UDI-DI
- 00647529003190 EUDAMED00647529003398 EUDAMED00647529003381 EUDAMED00647529003404 EUDAMED00647529003220 EUDAMEDFDA UDI00647529003367 EUDAMED
- Basic UDI-DI
- B-00647529003190 EUDAMEDB-00647529003398 EUDAMEDB-00647529003381 EUDAMEDB-00647529003404 EUDAMEDB-00647529003220 EUDAMEDB-00647529003367 EUDAMED
- 510(k) Number
- K163128 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 — 300 Micrometer FDA UDIOuter Diameter — 400 Micrometer FDA UDILength — 4 Millimeter FDA UDI
Diode Laser Tips - Pre 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-00647529003190 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 (7)
- EUDAMED 1947a820-e3ab-4a70-b0c1-255ad8d1f5d2 61 fields · synced Sep 18, 2026
- EUDAMED 188d3884-a292-4854-967a-124b729cf747 61 fields · synced May 11, 2026
- EUDAMED fc03a358-c297-4681-a206-cde92c7909b5 61 fields · synced May 17, 2026
- EUDAMED 80f91668-c097-45ad-a1c1-d7534cc47bf8 61 fields · synced May 18, 2026
- EUDAMED 2a2ce3a4-83b5-4109-943b-4c9b9dedd931 61 fields · synced May 18, 2026
- EUDAMED ffad27f9-f1c2-4ad0-a973-aab0a33d56b5 61 fields · synced May 18, 2026
- FDA UDI 3029f72d-06ca-4dbd-bcbe-c58db517df87 37 fields · synced May 29, 2026