Prettau® Zirconia 95H16

Basic Information

• Brand Name: Prettau® Zirconia 95H16
• Primary DI: D800ZRAD8031
• Version / Model: ZRAD8031
• Company Name: ZIRKONZAHN SRL
• Labeler DUNS: 564251911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 36c1cb26-7b99-4675-ba5f-c25be3a367a9

Device Description

Content: 1 piece Height: 16 mm Highly translucent zirconia for single crowns to large bridges (fully anatomic structures or reduced structures for veneering with ceramics)

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	POWDER, PORCELAIN	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38615	Dental bridge, ceramic	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D800ZRAD8031	HIBCC

Customer Contacts

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