Identity
- Trade Name
- Molar Procedure Instrument FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- The Molar Procedure Instrument, when used with the 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 procedure site. FDA UDI
- Model / Reference
- FG-001-00019 FDA UDI
- Description
- The Molar Procedure Instrument, when used with the 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 procedure site. FDA UDI
Identifiers
- Catalog Number
- GW-MOL-TIXX FDA UDI
- Primary DI / UDI-DI
- 00858395006004 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
- Not 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
Molar Procedure Instrument by Sonendo, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Sonendo, Inc.
Sources (1)
- FDA UDI 2f69aefe-43fa-44a2-80d1-52500c2d71f2 37 fields · synced Jun 6, 2026