AccessGUDID - DEVICE: IPS Empress CAD (DIVO6657271)

GUDID

Device Identifier (DI) Information

Brand Name: IPS Empress CAD
Version or Model: 665727
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 665727
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO6657271
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: materials for inlays, onlays, crowns and bridges

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Dental prosthesis fabrication material, ceramic	A dental material made of ceramic materials e.g., zirconium oxide, intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is and is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology.

FDA Product Code

[?]

Product Code	Product Code Name
EIH	POWDER, PORCELAIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2180dc8e-c60f-4c18-a9d0-10221c3eeb38
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 07, 2016