Submission Details
| 510(k) Number | K241314 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 10, 2024 |
| Decision Date | August 16, 2024 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
KLS Martin Oral-Max Implants MR Conditional (bundled)
Aug 2024
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K241314 is an FDA 510(k) clearance for the KLS Martin Oral-Max Implants MR Conditional (bundled), a Plate, Bone (Class II — Special Controls, product code JEY), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on August 16, 2024, 98 days after receiving the submission on May 10, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.
Device Classification
| Product Code | JEY — Plate, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4760 |
Manufacturer
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