Product code DZJ— Dental
KLS Martin Individual Patient Solutions (IPS) Planning System
- Classification name
- Driver, Wire, And Bone Drill, Manual
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Total cleared
- 32
- First cleared
- Most recent
Market context for product code DZJ
FDA has cleared devices under product code DZJ between 1976 and 2026, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2015
- 2014
- 2012
- 2004
- 1994
- 1992
Top applicants under product code DZJ
Recent clearances under product code DZJ
- K261826 — VSP System (Titanium Palatal Splint)
- K243637 — Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
- K242263 — TECHFIT DISRP® System
- K231520 — tmCMF Solution
- K230276 — TECHFIT DISRP® System
- K223024 — MedCAD AccuPlan System
- K220366 — EmbedMed
- K220648 — OMF ASP System
- K212570 — OsteoPlan System
- K201353 — CenterMed Patient Matched Assisted Surgical Planning (ASP) System
- K193301 — coDiagnostiX
- K210347 — VSP System
- K193499 — DigiGuide System
- K192282 — MedCAD® AccuPlan® System
- K181813 — ImmersiveView Surgical Plan (IVSP®)
- K192192 — VSP System
- K182789 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K181241 — KLS Martin Individual Patient Solutions (IPS) Planning System
- K172164 — PROPEL Device
- K150392 — PROPEL device
- K150796 — Dental Bone Cutting Instruments
- K133907 — VSP SYSTEM
- K120956 — VSP SYSTEM
- K040369 — STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
- K943540 — SURGICAL CUTTING BURS
- K915848 — SENSORMEDICS MODEL 2450 PULMONARY FUNCTION LAB.
- K894150 — COUNTERBORE FOR SS SUBMERGED SCREW PLANT
- K894151 — IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANT
- K883922 — TECHMEDICA I.B.O. BLADE
- K871834 — DRILL, HAND, BONE, SMEDBERG
- K781974 — IMPLANT DRIVERS AND TIPS
- K760960 — SURGICAL WIRE DRIVER
Data sourced from openFDA. This site is unofficial and independent of the FDA.