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Surgical devices · 21 CFR 872 Subpart E

Manual Wire Driver and Bone Drill

FDA device type “Driver, Wire, And Bone Drill, Manual”.

FDA codeDZJClass221 CFR872.4120Pathway510(k)CategorySurgical drills & motors
Companies listing it
3025 makers
Brands and models
52
510(k) clearances
3310 in five years
FDA name
Driver, Wire, And Bone Drill, Manual
1976: 11978: 11987: 11988: 11989: 21992: 11994: 12004: 12012: 12014: 12015: 22018: 22019: 12020: 42021: 32022: 32023: 32024: 12025: 12026: 219801990200020102020

510(k) clearances per year, 1976–2026

Companies that list DZJ

30 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakercoDiagnostiX · Surgical Guide with Cut Profile2122026
Dentsply Sirona, Inc.United StatesMaker—1482026
KLS Martin SE & Co. KGGermanyMaker—432026
StrykerUnited StatesMakerCORE System · Delta System · Pi Drive 2 Motor · Pi Drive 2 Plus Motor · +3332024
Materialise NVBelgiumMakerCMF Plastic Models · CMF Titanium Guides · Materialise Mimics Enlight CMF · Materialise Personalized Guides and Models for Craniomaxillofacial Surgery · +452026
MedCADUnited StatesMakerAccuPlan System 3DTi42023
Osteomed, LLCUnited StatesMaker—262022
W&H Dentalwerk Buermoos GmbHAustriaMaker—172026
3D Systems, Inc.United StatesMakerJaw in a Day · VSP Distraction · VSP Orthognathics · VSP Reconstruction · +232026
3D LifePrints UKUnited KingdomMakerEmbedMed12022
Biomet MicrofixationUnited StatesMakerPre-bent Plates with Virtual Surgical Planning · Virtual Surgical Planning · VSP82021
SYNTHES (USA) Products LLCUnited StatesMakerDental Bone Cutting Instruments · Synthes 90 Degree Screwdriver72020
SYNTHES GMBH / Synthes Produktions GmbHUnited StatesMakerDental Bone Cutting Instruments · Synthes 90 Degree Screwdriver52013
ImmersiveTouchUnited StatesMakerImmersiveView Surgical Plan12020
Unique Instruments Inc.United StatesMakercross cut fissure bur · DENTAL BONE CUTTING INSTRUMENTS——
Jabil Inc.United StatesMaker———
Straits Orthopaedics (Mfg) Sdn BhdMalaysiaMaker5400-007-017 PRESS RING · 5400-007-018 THIN BRONZE WASHER · 5400-007-020 LIGHT PIPE · 5400-007-023 THICK BRONZE WASHER——
Precision Edge Surgical Products CompanyUnited StatesMakerCOUNTERSINK W/CENTERING PINS FOR 2.4MM SCREWS/HEX COUPLING · COUNTERSINK W/CENTERING PINS FOR 2MM SCREWS/HEX COUPLING——
Baechler Feintech AGSwitzerlandMakerShaft f/Screwdriver 90°——
Sphinx Tools LtdSwitzerlandMakerSYNTHES——
The Anspach Effort IncUnited StatesMakerSynthes——
Acumed LLCUnited StatesMaker———
Avalign Instruments & ImplantsUnited StatesMaker———
Hipp Medical AGGermanyMaker———
KLS Martin Manufacturing, LLCUnited StatesMaker———
Sotera Health LLCUnited StatesContract manufacturerPropel Device, RT open / Closed · Propel Device, XL——
Exel Inc. dba DHL Supply Chain (USA)United StatesRepacker / relabelerDental Bone Cutting Instruments · SYNTHES 90 DEGREE SCREWDRIVER——
DePuy Synthes, Inc.United StatesManufacturerDental Bone Cutting Instruments · Synthes 90 Degree Screwdriver——
Sanmed Medikal Otomotiv Tekstil Ticaret Limited SirketiTürkiyeForeign exporterBURR——
Steritech, Inc.United StatesContract sterilizerD186182——

510(k) clearances

Decided510(k)DeviceApplicant
9 Oct 2026K260913CMF Titanium SplintsMaterialise NV
3 Jun 2026K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.
21 Feb 2025K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV
11 Dec 2024K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.
2 Oct 2023K231520tmCMF SolutionTechmah Cmf
23 Jun 2023K230276TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.
7 Mar 2023K223024MedCAD AccuPlan SystemMedCAD
30 Sep 2022K220366EmbedMed3D LifePrints UK
11 Aug 2022K220648OMF ASP SystemVha Dean
11 Feb 2022K212570OsteoPlan SystemOsteomed, LLC
28 Jun 2021K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.
21 Jun 2021K193301coDiagnostiXInstitut Straumann AG
26 Apr 2021K210347VSP System3D Systems, Inc.
4 Nov 2020K193499DigiGuide SystemProtomed, Inc.
29 Oct 2020K192282MedCAD® AccuPlan® SystemMedCAD
9 Jun 2020K181813ImmersiveView Surgical Plan (IVSP®)ImmersiveTouch
26 Feb 2020K192192VSP System3D Systems, Inc.
11 Mar 2019K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS Martin SE & Co. KG
13 Sep 2018K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS Martin SE & Co. KG
17 Jan 2018K172164PROPEL DevicePropel Orthodontics, LLC
18 Sep 2015K150392PROPEL devicePropel Orthodontics, LLC
23 Jun 2015K150796Dental Bone Cutting InstrumentsSYNTHES (USA) Products LLC
22 Jan 2014K133907VSP SYSTEMMedical Modeling, Inc.
12 Dec 2012K120956VSP SYSTEMMedical Modeling, Inc.
1 Apr 2004K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMStryker
30 Nov 1994K943540SURGICAL CUTTING BURSStryker
28 Oct 1992K915848SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.Sensor Medics Corp.
27 Sep 1989K894151IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANTArtech Corp.
27 Sep 1989K894150COUNTERBORE FOR SS SUBMERGED SCREW PLANTArtech Corp.
8 Dec 1988K883922TECHMEDICA I.B.O. BLADETechmedica, Inc.
31 Jul 1987K871834DRILL, HAND, BONE, SMEDBERGMilitary Engineering, Inc.
28 Dec 1978K781974IMPLANT DRIVERS AND TIPSMiter, Inc.
19 Nov 1976K760960SURGICAL WIRE DRIVERAmerican Safety Equipment Corp.

Official records: FDA product classification for DZJ · 21 CFR 872.4120.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026