SET ZZ BASE Z-TS-ICOTH 3.5 (Impression coping open tray hex and Screw

Basic Information

• Brand Name: SET ZZ BASE Z-TS-ICOTH 3.5 (Impression coping open tray hex and Screw
• Primary DI: D800BSAQ1141
• Version / Model: BSAQ1141
• Company Name: ZIRKONZAHN SRL
• Labeler DUNS: 564251911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-27
• Public Version: 1
• Public Version Date: 2021-10-05
• Public Version Status: New
• Public Device Record Key: 5b0765bd-8bae-4e02-a251-65a41f057f83

Device Description

Compatible with Zimmer Dental Tapered Screw-Vent implants Set consisting of: 1x Impression coping HEX 1x Screw for Impression coping 1x Driver for Impression coping open tray

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: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
46122	Dental implant suprastructure, temporary, preformed, reusable	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D800BSAQ1141	HIBCC

Customer Contacts

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