AccessGUDID - DEVICE: e.max Ceram (DIVO681629EN1)

GUDID

Device Identifier (DI) Information

Brand Name: e.max Ceram
Version or Model: 681629EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 681629EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO681629EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS e.max Ceram Power Dentin A2, Power Incisal 1, IPS Build-Up Liquid allround, Ivocolor Shade Dentin SD1, Ivocolor Shade Incisal SI3, Ivocolor Essence E 04 sunset, Ivocolor Essence E 10 mahogany, Ivocolor Glaze Powder FLUO, Ivocolor Glaze Paste FLUO, Ivocolor Mixing Liquid allround

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: 9b3ebfd9-d47f-46d0-b393-94b3b6c8bc59
Public Version Date: February 11, 2022
Public Version Number: 3
DI Record Publish Date: September 27, 2018