AccessGUDID - DEVICE: PS e.max Ceram (DIVO681628EN1)

GUDID

Device Identifier (DI) Information

Brand Name: PS e.max Ceram
Version or Model: 681628EN
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 681628EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO681628EN1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 19
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS e.max Ceram ZirLiner 5 g, 1IPS e.max C Margin A2 5 g, IPS e.max C Deep Dentin A2 5 g, IPS e.max C Dentin A2 5 g, IPS e.max C Transpa incisal 1 5 g, IPS e.max C Transpa clear 5 g, IPS e.max C Opal Effect 1 5 g, IPS e.max C Opal Effect 3 5 g, IPS e.max C Occl. Dentin orange 5 g, IPS e.max C Mamelon light 5 g, IPS Ivocolor Essence 1.8g E01 white, IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Essence 1.8g E10 maho, Ivocolor Shade Dentin SD2 3g, IPS Ivocolor Glaze Powder FLUO 1.8g, IPS e.max C ZirLiner Liquid 15 ml, IPS e.max C Margin Liquid allround 15 ml, Build-Up Liquid 15ml allround, Ivocolor Mixing Liquid allround 15ml

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: a1228a3d-9257-484d-a1ec-358cc3d6eefe
Public Version Date: February 19, 2021
Public Version Number: 1
DI Record Publish Date: February 11, 2021