Identity
- Trade Name
- Molar Procedure Instrument with Accessories FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar 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-001-00022 FDA UDI
- Description
- The Molar Procedure Instrument, when used with the Sonendo GentleWave Console, is intended to be used on the 1st and 2nd molar 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-MOL-PI01 FDA UDI
- Primary DI / UDI-DI
- 00858395006189 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
Molar Procedure Instrument with Accessories 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 0a9f96dd-11ec-434e-a8b4-5120d86181ab 36 fields · synced May 30, 2026