Biodenta

Basic Information

• Brand Name: Biodenta
• Primary DI: 07640169732287
• Version / Model: CAD-CASZSV345
• Catalog Number: CAD-CASZSV345
• Company Name: Biodenta Swiss AG
• Labeler DUNS: 484609081
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2016-09-29
• Public Version: 4
• Public Version Date: 2020-09-22
• Public Version Status: Update
• Public Device Record Key: c5df00d5-1248-47de-9abd-51dc9021f0c9

Device Description

Abutment Screw Compatible with Zimmer Screw Vent 3.5/4.5/5.7

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
NHA	Abutment, Implant, Dental, Endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61647	Dental prosthesis/implant abutment screw	A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07640169732287	GS1
Unit of Use	97640169732280	GS1

Premarket Submissions

Submission Number	Supplement Number
K151295	000