Identity
- Trade Name
- Waterlase Laser Tips FDA UDI
- Generic Name
- Dental solid-state laser system FDA UDI
- Device Name
- A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems. FDA UDI
- Model / Reference
- MZ6-12 FDA UDI
- Description
- A single-use fiberoptic accessory intended for use with Waterlase Laser delivery systems. FDA UDI
Identifiers
- Catalog Number
- 6200224 FDA UDI
- Primary DI / UDI-DI
- 00647529000922 FDA UDI
- 510(k) Number
- K101658 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dental solid-state 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
- Outer Diameter — 600 Micrometer FDA UDILength — 12 Millimeter FDA UDI
Category: Dental solid-state laser system
Waterlase Laser Tips by Biolase, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental solid-state laser system.
- TIP for LITETOUCH — Light Instruments · Class II
- TIP for LITETOUCH — Light Instruments · Class II
- E1 Handpiece, LT — Light Instruments · Class II
- InPulse Dental Laser — Beyond International Inc. · Class II
- Straight Handpiece, LT — Light Instruments · Class II
- EdgePRO™ — US Endodontics, LLC · Class II
- TIP for LITETOUCH — Light Instruments · Class II
- DEKA SMARTPERIO — EL.EN. SPA · Class II
Cleared under the same submission
K101658 also covers:
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase Laser Tips — Biolase, Inc.
- Waterlase 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 40b5894b-8949-4f2b-86b0-0eb8b61305a6 37 fields · synced Jun 1, 2026