FDA.reportPublic FDA data

FlowLogic Assert

Primary DI
00810209421175
Brand
FlowLogic Assert
Company
SONENDO, INC.
Model
FG-016-00008-04
Catalog number
FLG12V0221
Device description
FlowLogic Assert Shaping File 12 Variable, 21mm
Published
2025-12-26
Public version status
New
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
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810209421175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810209421175008102094211758102094211750810209421175

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store files in a clean, dry, and dust-free place

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8447663636info@sonendo.com

Regulatory Flags#

DUNS number
828894373
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
00810213812419EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812426EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812433EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812440EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812457EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812464EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812471EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812488EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812495EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812501EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812518EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812525EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812532EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812549EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812556EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812563EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812570EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812587EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812594EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812600EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812617EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812624EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812631EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812648EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812655EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812662EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812679EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812686EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812693EdgeEndoHSG-S Corp.EKS2026-06-24
00810213812709EdgeEndoHSG-S Corp.EKS2026-06-24