AccessGUDID - DEVICE: IPS e.max CAD (DIVO666816AN1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS e.max CAD
Version or Model: 666816AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 666816AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO666816AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: May 26, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Telio CAD for PlanMill Blocks, Telio CS Link transparent, Telio CS Desensitizer, IPS Empress CAD for Plan Mill Blocks, IPS Empress Universal Shade, IPS Empress Universal Stains, IPS Empress Universal Glaze, IPS Empress Universal Glaze and Stains Liquid, IPS e.max CAD for PlanMill Blocks, IPS e.max CAD Crystall./Shade, IPS e.max CAD Crystall./Stains, IPS e.max CAD Crystall./Glaze Paste, IPS e.max CAD Crystall./Glaze Liquid, IPS e.max CAD Crystallization Tray, Multilink Primer, Monobond Plus, IPS Ceramic Etching Gel, Multilink Automix, var. accessories

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:	No
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16187	Dental appliance 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 used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	Active	false

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: 28f7a065-0561-4b8a-8041-67d5ad0b99ec
Public Version Date: May 26, 2020
Public Version Number: 3
DI Record Publish Date: September 27, 2018