KLS Martin IPS Preprosthetic— 510(k) K210228

Substantially Equivalent

KLS-Martin L.P.

FDA 510(k) clearance K210228 for KLS Martin IPS Preprosthetic, Substantially Equivalent on 2022-07-08. Applicant: KLS-Martin L.P.. Device class: 2.

Clearance details

Applicant: KLS-Martin L.P.
Product code: Code ELE
Device class: Class 2
Regulation: 21 CFR 872.3645
Advisory panel: Dental
Date received: 2021-01-28
Decision date: 2022-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELE

K862926 — SURGICAL VITEX1986-08-29
K843557 — K-APATITE 20-40 MESH K-APATITE 40-601984-11-30
K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT1980-05-28

More clearances from KLS-Martin L.P.

K260137 — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more2026-08-17
K253660 — KLS Martin Pure Pectus System2026-02-20
K254162 — KLS Martin Ixos System2026-02-20
K250988 — KLS Martin Pure Pectus System2025-12-11
K250865 — KLS Martin IPS Forearm System2025-11-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.