FlowLogic Access FLGSXV0019

GUDID 00810209420901

FlowLogic Access Starter File SX, 19mm

SONENDO, INC.

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device ID00810209420901
NIH Device Record Key4f3818c3-6321-477b-935c-5fb40c4ec630
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlowLogic Access
Version Model NumberFG-016-00009-01
Catalog NumberFLGSXV0019
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
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
Special Storage Condition, SpecifyBetween 0 and 0 *Store files in a clean, dry, and dust-free place

Device Identifiers

Device Issuing AgencyDevice ID
GS100810209420901 [Primary]

FDA Product Code

EKSFile, Pulp Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


[00810209420901]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-05
Device Publish Date2025-12-26

Devices Manufactured by SONENDO, INC.

00810209420031 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 10/.06, 21mm
00810209420451 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 10/.04, 31mm
00810209420468 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 10/.06, 25mm
00810209420475 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 10/.06, 31mm
00810209420536 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.04, 31mm
00810209420543 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 21mm
00810209420550 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 25mm
00810209420567 - FlowLogic Assert2026-01-05 FlowLogic Assert Shaping File 15/.06, 31mm

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