Implant Drivers and Tips

FDA 510(k) K781974 · Miter, Inc.

Substantially Equivalent

510(k) numberK781974

Submission

Device name
Implant Drivers and Tips
Applicant
Miter, Inc.
Walker, MI, US
Received
November 27, 1978
Decision date
December 28, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DZJ – Driver, Wire, And Bone Drill, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

Other 510(k)s with product code DZJ

510(k)DeviceApplicantDecision
K261826VSP System (Titanium Palatal Splint)DZJ · Traditional 3D Systems, Inc.06/03/2026SE
K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional Materialise NV02/21/2025SE
K242263TECHFIT DISRP® SystemDZJ · Traditional Techfit Digital Surgery, Inc.12/11/2024SE
K231520tmCMF SolutionDZJ · Traditional Techmah Cmf10/02/2023SE
K230276TECHFIT DISRP® SystemDZJ · Traditional Techfit Digital Surgery06/23/2023SE
K223024MedCAD AccuPlan SystemDZJ · Traditional Medcad03/07/2023SE
K220366EmbedMedDZJ · Traditional 3D Lifeprints UK , Ltd.09/30/2022SE
K220648OMF ASP SystemDZJ · Traditional Vha Dean08/11/2022SE
K212570OsteoPlan SystemDZJ · Traditional Osteomed, LLC02/11/2022SE
K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional Centermed, Inc.06/28/2021SE

Questions and answers

When was Implant Drivers and Tips cleared by the FDA?

Implant Drivers and Tips (K781974) received a 510(k) decision of Substantially Equivalent on December 28, 1978, 31 days after the submission was received.

What is the product code of K781974?

The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.