AccessGUDID - DEVICE: IPS e.max CAD (DIVO690813AL1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS e.max CAD
Version or Model: 690813AL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 690813AL
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO690813AL1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 27, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS e.max CAD for CEREC/inLab A14 block, IPS e.max CAD for CEREC/inLab I12 block, IPS e.max CAD for CEREC/inLab C14 block, IPS e.max CAD for CEREC/inLab B32 block, IPS Empress CAD for CEREC/inLab I12 block, IPS Empress CAD for CEREC/inLab C14 blocks, IPS .max ZirCAD for CEREC/inLab C17 block, IPS e.max ZirCAD for CEREC/inLab B45 block, Telio CAD for CEREC/inLab B40L block, Telio CAD for CEREC/inLab A16 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, SR Connect, Monobond Plus, Multilink Hybrid Abutment, 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: 043100db-887c-4422-a3e8-d0141506c858
Public Version Date: January 27, 2021
Public Version Number: 3
DI Record Publish Date: September 27, 2018