FDA.reportPublic FDA data

510(k) K243910

Device
Retraxil
Applicant
Kulzer, LLC
510(k) number
K243910
Product code
MVL
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-24
Date received
2024-12-19
Classification name
Cord, Retraction
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Lucas Harmon
Address
4315 S Lafayette Blvd. South Bend IN US 46614 46614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K162662GingiDent Gingival Retraction PastePac-Dent International, Inc.2017-10-20
K162948Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction Cord/MaterialsKerr Corporation2017-08-08
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K162164GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordKerr Corporation2017-01-13
K152064Astringedent ClearUltradent Products, Inc.2015-09-24
K150423EXPAZENProduits Dentaires Pierre Rolland (Acteon Group)2015-07-08