Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KLS Martin Oral-Max Implants MR Conditional (bundled)

K-Number: K241314 · 2024-08-16

Decision Date2024-08-16
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KLS Martin Oral-Max Implants MR Conditional (bundled) is a medical device manufactured by KLS-Martin L.P.. It received FDA 510(k) clearance on 2024-08-16 under approval number K241314. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLS Martin Oral-Max Implants MR Conditional (bundled)?

KLS Martin Oral-Max Implants MR Conditional (bundled) is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by KLS-Martin L.P.. The 510(k) number is K241314.

When was KLS Martin Oral-Max Implants MR Conditional (bundled) approved by the FDA?

KLS Martin Oral-Max Implants MR Conditional (bundled) received FDA 510(k) clearance on 2024-08-16, under approval number K241314.

What company makes KLS Martin Oral-Max Implants MR Conditional (bundled)?

KLS Martin Oral-Max Implants MR Conditional (bundled) is manufactured by KLS-Martin L.P..

What is the FDA product code for KLS Martin Oral-Max Implants MR Conditional (bundled)?

The FDA product code for KLS Martin Oral-Max Implants MR Conditional (bundled) is JEY.

Other Devices by KLS-Martin L.P.

View all 21 devices →

Related Devices (Code: JEY)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.