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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K260137
Device Name KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions
Applicant
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Applicant Contact Melissa Bachorski
Correspondent
KLS-Martin L.P.
11201 Saint Johns Industrial Pkwy. S
Jacksonville,  FL  32246
Correspondent Contact Tugce Kalin
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Codes
DZJ   GXN   GXP   LLZ  
Date Received01/16/2026
Decision Date 08/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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