Implant-One

Basic Information

• Brand Name: Implant-One
• Primary DI: D762KITREIN000
• Version / Model: KIT-REIN-00
• Company Name: Implant Logistics, Inc.
• Labeler DUNS: 079280537
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-30
• Public Version: 2
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 34930325-dd4a-47db-93d0-8d9962ffe235

Device Description

300, 400, 500 Series Restorative Instrument Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFY	Dental Implant Surgical Tray	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44901	Dental torque wrench	A hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial marker (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.	No	Active
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active
45319	Dental implant extractor	A manually-operated, one-piece dental device intended to be used to retrieve an in situ dental implant [i.e., anchorage and/or retention (abutment) component], typically because of damage (e.g., a broken collar) or malfunction, from the oral cavity. It typically has a cylindrical design and a cavity or threaded shaft at the working distal end intended to grip or be inserted into the implant. It may have a handle at the proximal end or be used in conjunction with a drill and/or a separate handle or wrench (not included); it is not a collection of devices (i.e., not a kit). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D762KITREIN000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]