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Sonendo 17% EDTA

FDA UDI

Class I (US FDA UDI)

by Sonendo, Inc.

Identity

Trade Name
Sonendo 17% EDTA FDA UDI
Generic Name
Endodontic reaming aid material FDA UDI
Device Name
Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. FDA UDI
Model / Reference
FG-008-00001 FDA UDI
Description
Sonendo EDTA is a 17% EDTA chelating agent used for debriding and clearing the root canal during endodontic procedures. EDTA aids in the filing process by chelating calcium from dentin. FDA UDI

Identifiers

Catalog Number
GW-SYS-EDTA FDA UDI
Primary DI / UDI-DI
00858395006097 FDA UDI
510(k) Number
K961089 FDA UDI
FDA Product Code
EKL FDA UDI
GMDN Term
Endodontic reaming aid material FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.3840 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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endodontic reaming aid material

Sonendo 17% EDTA by Sonendo, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic reaming aid material.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sonendo, Inc.

Sources (1)

  • FDA UDI 9ee18f4e-4d3e-4359-952f-ab0cef0b6463 37 fields · synced Jun 8, 2026