AccessGUDID - DEVICE: IPS InLine (DIVO593003EN1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS InLine
Version or Model: 593003EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 593003EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO593003EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 10, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS InLine/IPS InLine PoM Opaque Paste, IPS InLine/IPS InLine PoM Glaze Paste, IPS InLine Dentin Powder, IPS InLine Incisal Powder, IPS InLine Transpa Powder, IPS InLine Add-On Powder, IPS InLine/IPS InLine PoM Build-Up Liquid, IPS InLine/IPS InLine PoM Opaquer Liquid, IPS InLine/IPS InLine PoM Glaze and Stains Liquid, IPS Model Sealer, IPS Ceramic Separating Liquid, Shade Guides, Chromascop Shade Guide

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: 246e1fc4-a4c0-4e80-b8d4-517abf59d4b5
Public Version Date: February 18, 2019
Public Version Number: 3
DI Record Publish Date: September 27, 2018