X-Ray Planning foil iSy® Implant System

Basic Information

• Brand Name: X-Ray Planning foil iSy® Implant System
• Primary DI: E219P530090101
• Version / Model: P5300.9010
• Catalog Number: P5300.9010
• Company Name: ALTATEC GmbH
• Labeler DUNS: 322018193
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 2
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: 3d8f1209-c133-424b-9974-c3ca0ac0f3b8
• Distribution End Date: 2023-06-15

Device Description

X-Ray Planning foil iSy® Implant System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47974	Dental implant x-ray template	A non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E219P530090101	HIBCC

Customer Contacts

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