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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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IPS Empress Direct Effect, IPS Empress… — 13 UDI-DI variants, MDR

MD Atlas
Ivoclar Vivadent AG

Data from EUDAMED, last updated May 30, 2026

IPS Empress Direct Effect, IPS Empress Direct Color, IPS Empress Direct Opaque, Tetric N-Effect 2, Tetric N-Color 2, Tetric N-Opaque 2

76152082AFILL015JM

13 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: Ivoclar Vivadent AG

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Device characteristics

Implantable

Identity & classification

Basic UDI-DI: 76152082AFILL015JM
Device name: IPS Empress Direct Effect, IPS Empress Direct Color, IPS Empress Direct Opaque, Tetric N-Effect 2, Tetric N-Color 2, Tetric N-Opaque 2
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Feb 10, 2026

Manufacturer & authorised representative

Manufacturer

Name: Ivoclar Vivadent AG
SRN: LI-MF-000000522
Country: Liechtenstein
Email: Sandro.Sbicego@ivoclar.com

Variants by status

UDI-DI variants

13 UDI-DI variants

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Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

Empress Direct Color Ref 1x1g blue07615208009682
Empress Direct Color Ref 1x1g brown07615208009712
Empress Direct Color Ref 1x1g grey07615208009736
Empress Direct Color Ref 1x1g honey07615208009675
Empress Direct Color Ref 1x1g ochre07615208009705
Empress Direct Color Ref 1x1g white07615208009668
Empress Direct Effect Ref. 1x1.8g Opal07615208009637
Empress Direct Opaque 1x1.8g07615208009651
Tetric N-Color 2 Refill 1x1g Brown07615208525861
Tetric N-Color 2 Refill 1x1g Ochre07615208525854
Tetric N-Color 2 Refill 1x1g White07615208525540
Tetric N-Effect 2 Ref 1x1.8g Trans Opal07615208525878
Tetric N-Opaque 2 Refill 1x1.8g07615208525885