IPS e.max Press

Basic Information

• Brand Name: IPS e.max Press
• Primary DI: DIVO745006EN1
• Version / Model: 745006EN
• Catalog Number: 745006EN
• Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT
• Labeler DUNS: 448015938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-11-23
• Public Version: 1
• Public Version Date: 2020-12-01
• Public Version Status: New
• Public Device Record Key: c7565f4a-c663-463e-961c-6c453653d944

Device Description

IPS e.max Ceram Transpa Incisal 20 g 1, IPS e.max Press LT A2 5 Stk., IPS e.max Press HT A2 5 Stk., IPS e.max Press Multi A2 5 Stk., IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Shade Dentin 3g SD2, IPS Ivocolor Shade Incisal 3g SI1, IPS Ivocolor Glaze Powder FLUO 1.8g, IPS Ivocolor Mix Liq allround 15ml, IPS e.max Press MT A2 5 Stk.

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: Yes
• 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
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	DIVO745006EN0	HIBCC
Primary	DIVO745006EN1	HIBCC