Identity
- Trade Name
- Diode Laser Tips FDA UDI
- Generic Name
- Dental diode laser system FDA UDI
- Device Name
- A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. FDA UDI
- Model / Reference
- perio, E3-9, single tip FDA UDI
- Description
- A single-use fiberoptic laser tip intended for use with Biolase diode laser systems. FDA UDI
Identifiers
- Catalog Number
- 6400302 FDA UDI
- Primary DI / UDI-DI
- 00647529000120 FDA UDI
- 510(k) Number
- K121286 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
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
- Length — 9 Millimeter FDA UDIOuter Diameter — 300 Micrometer FDA UDI
Category: Dental diode laser system
Diode Laser Tips by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental diode laser system.
- NV®PRO3 — Den-Mat Holdings, LLC · Class II
- NV® — Den-Mat Holdings, LLC · Class II
- Dental Diode Laser System — Lazon Medical Laser Co., Ltd. · Class II
- STERLING® — Den-Mat Holdings, LLC · Class II
- SOL® — Den-Mat Holdings, LLC · Class II
- BLU — Peter Brasseler Holdings, LLC · Class II
- Pioneer Elite Perio Tip — CAO GROUP, INC. · Class II
- SL3® — Den-Mat Holdings, LLC · Class II
Cleared under the same submission
K121286 also covers:
- Diode Laser System Deep Tissue Handpiece — Biolase, Inc.
- Diode Laser System Whitening Handpiece — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
- Diode Laser Tips — Biolase, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolase, Inc.
Sources (1)
- FDA UDI b26e4422-e54f-4577-9a07-ba8a72c1a7b5 37 fields · synced May 29, 2026