DZL · Class II · 21 CFR 872.4880

FDA Product Code DZL: Screw, Fixation, Intraosseous

Under FDA product code DZL, intraosseous fixation screws are cleared for bone fixation in dental and maxillofacial surgery.

These titanium or resorbable screws are used to stabilize osteotomized or fractured bone segments of the jaws and craniofacial skeleton, providing rigid fixation that allows primary bone healing without movement at the repair site.

DZL devices are Class II medical devices, regulated under 21 CFR 872.4880 and reviewed by the FDA Dental panel.

Leading manufacturers include Synthes (Usa), Hager& Meisinger GmbH and Osteomed Corp..

81
Total
81
Cleared
150d
Avg days
1976
Since
Growing category - 6 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 259d recently vs 141d historically

FDA 510(k) Cleared Screw, Fixation, Intraosseous Devices (Product Code DZL)

81 devices
1–24 of 81
Cleared Aug 24, 2026
Guided Bone Regeneration System
K254286
DentalMaster(Xiamen)Medical Technology Co., Ltd.
Dental · 236d
Cleared Sep 29, 2025
Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)
K250123
Hager& Meisinger GmbH
Dental · 255d
Cleared Aug 13, 2025
Bone Screw
K251569
Osstem Implant Co., Ltd.
Dental · 83d
Cleared Jun 27, 2025
USTOMED Bone Fixation/Bone Augmentation Systems - PIN
K243190
Ustomed Instrumente Ulrich Storz GmbH & Co. KG
Dental · 270d
Cleared Jan 03, 2025
GBR System
K233419
Proimtech Saglik Urunleri Anonim Sirketi
Dental · 451d
Cleared Oct 17, 2024
MP Pin flat without thread (36BMP000020/MP20)
K240321
Hager& Meisinger GmbH
Dental · 258d
Cleared Sep 17, 2024
KLS Martin Drill-Free MMF Screw
K233721
KLS-Martin L.P.
Dental · 301d
Cleared Aug 24, 2023
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599
Stryker Leibinger GmbH & Co KG
Dental · 84d
Cleared Mar 23, 2023
SAVE GBR
K222367
Dentis Co., Ltd.
Dental · 230d
Cleared Oct 08, 2021
The Micro Screw System, Micro Screw System Basic
K201210
Hager& Meisinger GmbH
Dental · 521d
Cleared Oct 05, 2020
Membrane Screws and Membrane Tacks
K201561
Neoss Limited
Dental · 117d
Cleared Aug 09, 2019
Bone Screw, Bone Tack
K182881
Osstem Implant Co., Ltd.
Dental · 298d
Cleared May 07, 2019
OssBuilder System
K181854
Osstem Implant Co., Ltd.
Dental · 300d
Cleared Oct 26, 2017
Intra-Lock Bone Fixation System
K171831
Intra-Lock International, Inc.
Dental · 128d
Cleared Apr 28, 2017
Salvin Tenting Screw System
K161857
Salvin Dental Specialties
Dental · 296d
Cleared Jan 10, 2017
Neo GBR System
K160991
Neobiotech Co., Ltd.
Dental · 277d
Cleared May 26, 2016
MC BIO Supertack Tack 3mm, 4mm and 5mm
K151540
Eli-Ka Technologies
Dental · 353d
Cleared Sep 21, 2015
OsteoMed IMF Screw
K151195
Osteomed
Dental · 140d
Cleared Oct 02, 2014
JUGGERKNOT MINI SOFT ANCHOR
K140908
Biomet Sports Medicine
Dental · 176d
Cleared Feb 14, 2014
DENTAL BONE SCREWS
K132212
Hager& Meisinger GmbH
Dental · 213d
Cleared Aug 13, 2013
MEISINGER TACS (MEISINGER MEITAC-KIT), MEISINGER PINS (MEISINGER MASTER-PIN-CONTROL-KIT, BASIC-KIT
K130682
Hager& Meisinger GmbH
Dental · 153d
Cleared Feb 08, 2011
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902
Jeil Medical Corporation
Dental · 215d
Cleared Jan 25, 2010
RAPIDSORB PLUS SCREW SYSTEM
K093464
Synthes (Usa)
Dental · 80d
Cleared Dec 29, 2009
MILTEX MEMBRANE TACK KIT
K092855
Miltex, Inc.
Dental · 104d

About Product Code DZL - Regulatory Context

510(k) Submission Activity

81 total 510(k) submissions under product code DZL since 1976, with 81 receiving FDA clearance (average review time: 150 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DZL Product Code

Recent submissions under DZL have taken an average of 259 days to reach a decision - up from 141 days historically. Manufacturers should account for longer review timelines in current project planning.

DZL devices are reviewed by the Dental panel. Browse all Dental devices →