FDA.reportPublic FDA data

Sonendo 17% EDTA

Primary DI
00858395006097
Brand
Sonendo 17% EDTA
Company
SONENDO, INC.
Model
FG-008-00001
Catalog number
GW-SYS-EDTA
Device 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.
Published
2017-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKLPoint, Silver, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKLPoint, Silver, EndodonticDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961089000PULPDENT ENDOPREP IIPulpdent Corp.1996-04-23EKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858395006097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858395006097008583950060978583950060970858395006097

GMDN Terms#

Term, Definition table
TermDefinition
Endodontic reaming aid materialA liquid or gel substance typically used during root canal procedures as a chelating agent for chemical reaming to aid mechanical reaming, or as a lubricant to facilitate endodontic instrument penetration. It will typically have bactericidal properties. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius27 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8447663636info@sonendo.com

Regulatory Flags#

DUNS number
828894373
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810209420031FlowLogic AssertFG-016-00007-03FLG10C06212025-12-26
00810209420451FlowLogic AssertFG-016-00006-63FLG10C04312025-12-26
00810209420468FlowLogic AssertFG-016-00007-33FLG10C06252025-12-26
00810209420475FlowLogic AssertFG-016-00007-63FLG10C06312025-12-26
00810209420536FlowLogic AssertFG-016-00006-65FLG15C04312025-12-26
00810209420543FlowLogic AssertFG-016-00007-05FLG15C06212025-12-26
00810209420550FlowLogic AssertFG-016-00007-35FLG15C06252025-12-26
00810209420567FlowLogic AssertFG-016-00007-65FLG15C06312025-12-26
00810209420628FlowLogic AssertFG-016-00006-66FLG20C04312025-12-26
00810209420635FlowLogic AssertFG-016-00007-06FLG20C06212025-12-26
00810209420642FlowLogic AssertFG-016-00007-36FLG20C06252025-12-26
00810209420659FlowLogic AssertFG-016-00007-66FLG20C06312025-12-26
00810209420680FlowLogic AssertFG-016-00006-67FLG25C04312025-12-26
00810209420697FlowLogic AssertFG-016-00007-07FLG25C06212025-12-26
00810209420703FlowLogic AssertFG-016-00007-37FLG25C06252025-12-26
00810209420710FlowLogic AssertFG-016-00007-67FLG25C06312025-12-26
00810209420734FlowLogic AssertFG-016-00006-38FLG30C04252025-12-26
00810209420741FlowLogic AssertFG-016-00006-68FLG30C04312025-12-26
00810209420758FlowLogic AssertFG-016-00007-08FLG30C06212025-12-26
00810209420765FlowLogic AssertFG-016-00007-38FLG30C06252025-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8091011RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D8091031RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D8097031RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D809PL2081RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D809PL2091RoydentROYDENT DENTAL PRODUCTS INCEKL2016-10-07
D701FILE2FILE-RITE™ PULPDENT CORPORATIONEKL2016-08-11
D701EDTA1202EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21
D701EDTA302EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21
D701EDTA4802EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21
D701EDTA602EDTA SOLUTION, 17%PULPDENT CORPORATIONEKL2016-07-21