FDA product code DZL: Screw, Fixation, Intraosseous
DZL is the FDA product code for screw, fixation, intraosseous. It is a Class II device, regulated under 21 CFR 872.4880 and reviewed by the Dental panel. FDA has cleared 81 510(k) submissions under DZL, 9 in the last five years, from 45 different applicants. The average 510(k) review took 150 days (median 109); 260 days on average over the last three years. FDA has posted 8 recalls for DZL devices.
Classification
| Field | Value |
|---|---|
| Device name | Screw, Fixation, Intraosseous |
| Device class | Class II |
| Regulation | 21 CFR 872.4880 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for DZL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 234 |
| 2019 | 2 | 299 |
| 2020 | 1 | 117 |
| 2021 | 1 | 521 |
| 2023 | 2 | 157 |
| 2024 | 2 | 280 |
| 2025 | 4 | 265 |
| 2026 | 1 | 236 |
Compare with all 510(k) review times · Search every DZL clearance
Top DZL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Synthes (Usa) | 13 | 2010-01-25 |
| Hager& Meisinger GmbH | 5 | 2025-09-29 |
| Osteomed Corp. | 4 | 2002-01-16 |
| Osstem Implant Co., Ltd. | 3 | 2025-08-13 |
| KLS-Martin L.P. | 3 | 2024-09-17 |
40 more applicants have DZL clearances. See the full list in Caduvo.
Most recent DZL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254286 | DentalMaster(Xiamen)Medical Technology Co., Ltd. | Guided Bone Regeneration System | 2026-08-24 | 236 |
| K250123 | Hager& Meisinger GmbH | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | 2025-09-29 | 255 |
| K251569 | Osstem Implant Co., Ltd. | Bone Screw | 2025-08-13 | 83 |
| K243190 | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | 2025-06-27 | 270 |
| K233419 | Proimtech Saglik Urunleri Anonim Sirketi | GBR System | 2025-01-03 | 451 |
Recalls for DZL devices
8 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-02-23.
Frequently asked questions
What is FDA product code DZL?
DZL is the FDA product code for screw, fixation, intraosseous. It is a Class II device, regulated under 21 CFR 872.4880 and reviewed by the Dental panel.
What device class is DZL?
Class II, regulation 21 CFR 872.4880. Typical premarket route: 510(k).
How long does a 510(k) take for product code DZL?
Across 81 cleared submissions the average was 150 days from receipt to decision (median 109).
Which companies have the most DZL clearances?
Synthes (Usa) (13); Hager& Meisinger GmbH (5); Osteomed Corp. (4); Osstem Implant Co., Ltd. (3); KLS-Martin L.P. (3).
Have DZL devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2016-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code DZL
- Run a recall and safety report across every DZL manufacturer
- Watch product code DZL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Dental product codes · FDA product code lookup · 510(k) database search · 510(k) review times