Implantswiss

Basic Information

• Brand Name: Implantswiss
• Primary DI: 07630188201772
• Version / Model: S-D/E
• Catalog Number: S-D/E
• Company Name: Novodent SA
• Labeler DUNS: 480055352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 3
• Public Version Date: 2021-05-18
• Public Version Status: Update
• Public Device Record Key: ba57dd16-bff1-4c14-ae19-87c605962cc0

Device Description

Drill Extension Implant system for the support of dental prostheses, aimed at restoring missing teeth for aesthetical and functional purposes. Instruments dedicated to implant system for the support of dental prostheses.

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45320	Dental drill bit extension	A device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630188201772	GS1