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Diode Laser Tips - Pre Initiated Tips
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 6400564
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, pre-initiated, Surgical Assortment, 30PK EUDAMEDAn assortment kit containing 30 single-use pre-initiated tips intended for use with Biolase diode laser delivery systems. The tips vary in length and core diameter. FDA UDI
- Model / Reference
- 6400564 EUDAMEDPre-initiated Surgical Assortment FDA UDI
- Description
- An assortment kit containing 30 single-use pre-initiated tips intended for use with Biolase diode laser delivery systems. The tips vary in length and core diameter. FDA UDI
Identifiers
- Catalog Number
- 6400564 FDA UDI
- Primary DI / UDI-DI
- 00647529003411 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00647529003411 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
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-00647529003411 | 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 (2)
- EUDAMED 1144a3ce-cd4c-41fc-a971-62db9b08131d 61 fields · synced Jun 20, 2026
- FDA UDI bc9245ec-003c-459c-a4dc-937f5a49406d 36 fields · synced May 30, 2026