AccessGUDID - DEVICE: IPS STYLE CERAM (DIVO679925EN1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS STYLE CERAM
Version or Model: 679925EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 679925
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO679925EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: October 16, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: IPS Style Ceram Pow. Opaquer 870 A1, A3, A3, A3.5, Deep Dentin A1, A2, A3, A3.5, Dentin A1, A2, A3, A3.5, Incisal I1, I2, I3, I4, 1x5g each Transpa neutral, Mamelon light, Occ. Dentin orange, Opal Effect 11, One 1, 2, 3, 4, IPS Ivocolor Shade Dentin SD1, SD2, Incisal SI1, IPS Ivocolor Essence EO1 white, EO4 sunset, E10 mahogany, E16 sapphire, IPS Ivocolor Glaze Pase, IPS Ivocolor Mixing Liquids (allround), IPS Pow. Opaquer Liquid, IPS Build-Up Liquid allround, Shade Guide IPS Style Ceram Impulse, Shade Guide IPS Style Ceram Incisal /Transpa

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: 4dfd3e5e-0c1d-4e04-b15d-d1cf0a4a43c9
Public Version Date: October 17, 2024
Public Version Number: 2
DI Record Publish Date: February 04, 2019