← Back to catalogue
Premolar CrossFire Procedure Instrument with Matrix
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Premolar CrossFire Procedure Instrument with Matrix FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- The Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site. FDA UDI
- Model / Reference
- FG-014-00003 FDA UDI
- Description
- The Premolar CrossFire Procedure Instrument with Matrix, when used with the Sonendo GentleWave Console, is intended to be used on premolar teeth indicated for root canal therapy. The device is a hand held dental instrument which contains both fluid delivery and fluid recovery pathways within a polymer casing. The exterior shape of the device is designed to fit the curvature of the human hand and allow ease of application to the treatment site. FDA UDI
Identifiers
- Catalog Number
- GW-PRE-XF01 FDA UDI
- Primary DI / UDI-DI
- 00858395006684 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental delivery system instrument unit, electric
Premolar CrossFire Procedure Instrument with Matrix by Sonendo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental delivery system instrument unit, electric.
- A-dec — A-Dec, Inc. · Class I
- DCI Edge — DCI International, LLC · Class I
- DTE — Guilin Woodpecker Medical Instrument Co., Ltd. · Class I
- SCALEX — Dentamerica · Class II
- DCI Edge — DCI International, LLC · Class I
- SCALEX — Dentamerica · Class II
- Standard Triton Self-Contained Delivery Systems — ASI MEDICAL, INC. · Class I
- Dentacenter Operative Dental Unit — Safari Dentaire Inc · Class I
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
- Sonendo, Inc.
Sources (1)
- FDA UDI 3c400e0c-cff8-4a14-a23c-3a82b5c51ffe 36 fields · synced May 30, 2026