AccessGUDID - DEVICE: IPS e.max CAD (DIVO740229AL1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS e.max CAD
Version or Model: 740229AL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 740229AL
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO740229AL1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 23
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 e.max CAD Crystall./Glaze Liquid15ml, IPS e.max CAD Crystall./Stains 1g sunset, IPS e.max CAD Crystall./Shade 3g I1, IPS e.max CAD Cryst/GlazePaste FLUO 3g , 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 CAD CER/inLab LT A2 A16 (L)/3, IPS e.max CAD CER/inLab LT A2 A14 (L)/5, Mixing Tips short tapered Refill/15, OptraGloss Test Pack, OptraGate Regular, OptraGate Small, OptraStick Test Pack/2, Cervitec Plus Test Pack 3x0.25g

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: b8a222c4-cfdb-4981-98b1-902f7c70368e
Public Version Date: January 28, 2021
Public Version Number: 1
DI Record Publish Date: January 20, 2021