AccessGUDID - DEVICE: IPS Style Ceram (DIVO701899EN1)

GUDID

Device Identifier (DI) Information

Brand Name: IPS Style Ceram
Version or Model: 701899EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 701899EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO701899EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: July 17, 2024
Device Count: 16
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: "IPS Style Ceram Paste Opaq 5g A2, IPS Style Ceram Deep Dentin A2 5g, IPS Style Ceram Dentin A2 5g, IPS Style Ceram Incisal I2 5g, IPS Style Ceram Transpa neutral 5g, IPS Style Ceram Mamelon light 5g, IPS Style Ceram Occ. Dentin orange 5g, IPS Style Ceram Opal Effect 1 5g, IPS Style Ceram One 2 5g, Ivocolor Shade Dentin SD2 3g, IPS Ivocolor Essence 1.8g E01 white, IPS Ivocolor Essence 1.8g E04 sunset, IPS Ivocolor Glaze Paste 3g, Ivocolor Mixing Liquid allround 15ml, IPS Paste Opaq. Liquid 15ml, Build-Up Liquid 15ml 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: a3568de3-e3d7-41cf-8582-c786eafcb168
Public Version Date: July 18, 2024
Public Version Number: 2
DI Record Publish Date: November 12, 2019