Ceramill

Basic Information

• Brand Name: Ceramill
• Primary DI: 08719425508849
• Version / Model: NPAGTITI001000
• Company Name: Vertex-Dental B.V.
• Labeler DUNS: 406389056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-13
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 0629bc4b-73a8-4fbb-8c50-6ccd6357d970

Device Description

3D printing material for Try-In devices, a baseplate combined with the individual designed tooth setup, to check bite registration and occlusion

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EEA	PLATE, BASE, SHELLAC	Dental	872.6200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61648	Dental prosthesis bite verification device	A device intended to aid in the fabrication of a dental prosthesis (e.g., crown, bridge) by connecting the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before production. It is affixed with a dental prosthetic screw or dental prosthetic screw analogu(also known as guide pin). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719425508849	GS1