Submission Details
| 510(k) Number | K233721 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 21, 2023 |
| Decision Date | September 17, 2024 |
| Days to Decision | 301 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
KLS Martin Drill-Free MMF Screw
Sep 2024
Decision
301d
Days
Class 2
Risk
About This 510(k) Submission
K233721 is an FDA 510(k) clearance for the KLS Martin Drill-Free MMF Screw, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on September 17, 2024, 301 days after receiving the submission on November 21, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.
Device Classification
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4880 |
Manufacturer
Similar Devices — DZL Screw, Fixation, Intraosseous
All 79
K250123 · Hager& Meisinger GmbH
· Sep 2025
K251569 · Osstem Implant Co., Ltd.
· Aug 2025
K243190 · Ustomed Instrumente Ulrich Storz GmbH & Co. KG
· Jun 2025
K233419 · Proimtech Saglik Urunleri Anonim Sirketi
· Jan 2025
K240321 · Hager& Meisinger GmbH
· Oct 2024
K231599 · Stryker Leibinger GmbH & Co KG
· Aug 2023
More from KLS-Martin L.P.
View all
K253660
· HRS · Feb 2026
K254162
· Feb 2026
K250988
· HRS · Dec 2025
K250865
· HRS · Nov 2025
K252573
· GXN · Nov 2025