FlowLogic Agile FLB35C0425

GUDID 00810209420321

FlowLogic Agile Shaping File 35/.04, 25mm

SONENDO, INC.

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID00810209420321
NIH Device Record Key90bec95e-a10e-4167-b9f9-25e62fe007e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowLogic Agile
Version Model NumberFG-016-00001-39
Catalog NumberFLB35C0425
Company DUNS828894373
Company NameSONENDO, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com
Phone8447663636
Emailinfo@sonendo.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place

Device Identifiers

Device Issuing AgencyDevice ID
GS100810209420321 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

[00810209420321]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-01
Device Publish Date2025-12-24

On-Brand Devices [FlowLogic Agile]

00810209421151FlowLogic Agile Shaping File Variable Kit, 25mm
00810209421144FlowLogic Agile Shaping File Variable Kit, 21mm
00810209421137FlowLogic Agile Shaping File 25 Variable, 31mm
00810209421120FlowLogic Agile Shaping File 20 Variable, 31mm
00810209421113FlowLogic Agile Shaping File 17 Variable, 31mm
00810209421106FlowLogic Agile Shaping File 14 Variable, 31mm
00810209421090FlowLogic Agile Shaping File 12 Variable, 31mm
00810209421083FlowLogic Agile Shaping File 10 Variable, 31mm
00810209421076FlowLogic Agile Shaping File 25 Variable, 25mm
00810209421069FlowLogic Agile Shaping File 20 Variable, 25mm
00810209421052FlowLogic Agile Shaping File 17 Variable, 25mm
00810209421045FlowLogic Agile Shaping File 14 Variable, 25mm
00810209421038FlowLogic Agile Shaping File 12 Variable, 25mm
00810209421021FlowLogic Agile Shaping File 10 Variable, 25mm
00810209421014FlowLogic Agile Shaping File 25 Variable, 21mm
00810209421007FlowLogic Agile Shaping File 20 Variable, 21mm
00810209420994FlowLogic Agile Shaping File 17 Variable, 21mm
00810209420987FlowLogic Agile Shaping File 14 Variable, 21mm
00810209420970FlowLogic Agile Shaping File 12 Variable, 21mm
00810209420963FlowLogic Agile Shaping File 10 Variable, 21mm
00810209420932FlowLogic Agile Shaping File .04 Kit, 25mm
00810209420925FlowLogic Agile Shaping File .04 Kit, 21mm
00810209420420FlowLogic Agile Shaping File 40/.06, 31mm
00810209420413FlowLogic Agile Shaping File 40/.06, 25mm
00810209420406FlowLogic Agile Shaping File 40/.06, 21mm
00810209420390FlowLogic Agile Shaping File 40/.04, 31mm
00810209420383FlowLogic Agile Shaping File 40/.04, 25mm
00810209420376FlowLogic Agile Shaping File 40/.04, 21mm
00810209420369FlowLogic Agile Shaping File 35/.06, 31mm
00810209420352FlowLogic Agile Shaping File 35/.06, 25mm
00810209420345FlowLogic Agile Shaping File 35/.06, 21mm
00810209420338FlowLogic Agile Shaping File 35/.04, 31mm
00810209420321FlowLogic Agile Shaping File 35/.04, 25mm
00810209420314FlowLogic Agile Shaping File 35/.04, 21mm
00810209420307FlowLogic Agile Shaping File 30/.06, 31mm
00810209420291FlowLogic Agile Shaping File 30/.06, 25mm
00810209420284FlowLogic Agile Shaping File 30/.06, 21mm
00810209420277FlowLogic Agile Shaping File 30/.04, 31mm
00810209420260FlowLogic Agile Shaping File 30/.04, 25mm
00810209420253FlowLogic Agile Shaping File 30/.04, 21mm
00810209420246FlowLogic Agile Shaping File 25/.06, 31mm
00810209420239FlowLogic Agile Shaping File 25/.06, 25mm
00810209420222FlowLogic Agile Shaping File 25/.06, 21mm
00810209420215FlowLogic Agile Shaping File 25/.04, 31mm
00810209420208FlowLogic Agile Shaping File 25/.04, 25mm
00810209420192FlowLogic Agile Shaping File 25/.04, 21mm
00810209420185FlowLogic Agile Shaping File 20/.06, 31mm
00810209420178FlowLogic Agile Shaping File 20/.06, 25mm
00810209420161FlowLogic Agile Shaping File 20/.06, 21mm
00810209420154FlowLogic Agile Shaping File 20/.04, 31mm
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