AccessGUDID - DEVICE: IPS E.MAX CAD (DIVO690811AL1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS E.MAX CAD
Version or Model: 690811AL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 690811
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO690811AL1
Issuing Agency: HIBCC
Commercial Distribution End Date: April 20, 2022
Device Count: 19
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS e.max CAD for PrograMill I12 block, IPS e.max CAD for PrograMill C14 block, IPS e.max CAD for PrograMill B32 block, IPS Empress CAD for PrograMill I12 block, IPS Empress CAD for PrograMill C14 block, IPS Empress CAD for PrograMill C14 L block, IPS e.max ZirCAD for PrograMill C17 block, IPS e.max ZirCAD for PrograMill B45 block, Telio CAD for PrograMill B40L block, IPS Object Fix Putty, IPS e.max CAD Crystall./Glaze Liquid, IPS e.max CAD Crystall./Stains, IPS e.max CAD Crystall./Glaze Paste Fluo, IPS e.max CAD Crystall./Shade, IPS e.max CAD Crystallization Tray, Telio CS Desensitizer, SpeedCEM Plus, Adhese Universal, Variolink Esthetic DC, Monobond Etch & Prime, Ivoclean, Liquid Strip, 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: aa3d972c-e800-4234-a5f4-5623a4d9b5c0
Public Version Date: April 21, 2022
Public Version Number: 2
DI Record Publish Date: March 02, 2020