Implantswiss

Basic Information

• Brand Name: Implantswiss
• Primary DI: 07640168183653
• Version / Model: S-ORLA
• Catalog Number: S-ORLA
• Company Name: Novodent SA
• Labeler DUNS: 480055352
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 2
• Public Version Date: 2021-05-24
• Public Version Status: Update
• Public Device Record Key: 1b6d0dc4-abc9-41a0-902a-9089f535aeed

Device Description

O-Ring Lab Analog "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: 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: 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
61640	Dental implant abutment analog, laboratory	A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640168183653	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from light and sun