AccessGUDID - DEVICE: IPS E.MAX CAD (DIVO703745AL1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS E.MAX CAD
Version or Model: 703745AL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 703745
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO703745AL1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 04, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS e.max CAD CEREC inLab HT A2 I12 5, IPS e.max CAD CEREC inLab MT A2 C14 5, IPS e.max CAD CEREC inLab LT A2 B32 3, IPS Object Fix Putty 10 g, IPS e.max CAD Crystall Glaze Liquid 15ml, IPS e.max CAD Crystall Glaze Liquid 15ml, IPS e.max CAD Crystall. Shade 3g I1, IPS e.max CAD Cryst GlazePaste FLUO 3g, IPS e.max CAD Crystallization Tray, IPS Empress CAD CEREC inLab HT A2 I12 5, IPS Empress CAD CEREC inLab LT A2 C14 5, Empress CAD CEREC inLab Multi A2 C14 L 5, Tetric CAD CEREC inLab HT A2 I12 5, Tetric CAD CEREC inLab MT A2 C14 5, IPS e.max ZirCAD CER in.MT Mul. A2 C17 5, IPS e.max ZirCAD CER in.MT Mul. A2 B45 3, Telio CAD CEREC inLab LT A2 B40L 3, Telio CS desensitizer 5g (Bulk), SR Connect 5 ml ohne FS, FLA Monobond Plus 1g Bulk, Telio CAD CER inLab LT A2 A16 (L) 3, IPS e.max CAD CER inLab LT A2 A14 (L) 5, Multilink Abutment DS SPR HO0 2.5g, Variolink Esthetic DC 2.5ml SPR ntr 2.5g, AdheSE Universal 0.5ml VivaPen (BULK), SpeedCEM2014 DS SPR2.5ml transp 2.5g, OptraPol Test Pack, OptraFine Promo Pack

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: 36f1ff89-fe74-4427-a81d-b67510422fb3
Public Version Date: February 07, 2022
Public Version Number: 2
DI Record Publish Date: April 29, 2019