510(k) clearances

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

KLS-Martin L.P. · Dental

K260137Substantially EquivalentTraditionalJEY
Open FDA's page for this record
Third party flag
N
City
Jacksonville
Advisory committee description
Dental
Address 1
11201 Saint Johns Industrial Pkwy. S
Statement or summary
Summary
Product code
JEY
Zip code
32246
Applicant
KLS-Martin L.P.
Decision date
2026-08-17
Decision code
SESE
Country code
US
Advisory committee
DE
Contact
Melissa Bachorski
K number
K260137
State
FL
Date received
2026-01-16
Review advisory committee
DE
Postal code
32246
Decision description
Substantially Equivalent
Clearance type
Traditional
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

Harmonized identifiers (openFDA)
Device name
Plate, Bone
Medical specialty description
Dental
Regulation number
872.4760
Device class
2
Registration number
1650372, 2029447, 1060818, 9610921, 3013111692, 2029275, 3031886796, 3027157194, 1647149, 1030489, 3005515228, 1226425, 3009555447, 3002862271, 3009383407, 3015531529, 2032098, 3009158523, 3025141, 3030089802, 3009196021, 1825034, 3004049923, 9681465, 3014128887, 3000270450, 3009555440, 2027754, 9610612, 1000606483, 2024024, 2530154, 3010363503, 9710629, 3006001176, 3009417901, 1649518, 3014937101, 9610905, 3003898943 +65 more
FEI number
3002806315, 3003646540, 3002807464, 3013111692, 3031886796, 3027157194, 3005515228, 3009555447, 3002807113, 3002862271, 3009383407, 3015531529, 1000221916, 3009158523, 3001236277, 3030089802, 3009196021, 1000185904, 1825034, 1000477302, 3004049923, 3014128887, 3000270450, 3009555440, 2027754, 1000606483, 3002821504, 2024024, 1000160570, 3010363503, 3003018882, 3006001176, 3009417901, 3014937101, 3002807041, 3003898943, 1032347, 2916714, 5870, 3015780293 +65 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.