510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210228Substantially Equivalent

KLS Martin IPS Preprosthetic

KLS-Martin L.P., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210228 is the FDA 510(k) clearance record for KLS Martin IPS Preprosthetic, a class II device, cleared for KLS-Martin L.P. on under FDA product code ELE (Implant, Subperiosteal). FDA records list 78 510(k) clearances for KLS-Martin L.P., from to . As of , FDA records show no recalls naming K210228.

Clearance record

Decision date
Received
(526 days to decision)
Product code
ELE Implant, Subperiosteal
Regulation
21 CFR 872.3645
Device class
Class II
Review panel
Dental
Applicant
KLS-Martin L.P. 11201 Saint Johns Industrial Pkwy. S, Jacksonville FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ELE

Trailing 12 months

FDA records hold no clearances under product code ELE in the trailing twelve months.

FDA records show no clearances under product code ELE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ELE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260