AccessGUDID - DEVICE: Tetric (DIVO692157EN1)

GUDID

Device Identifier (DI) Information

Brand Name: Tetric
Version or Model: 692157EN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 692157EN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO692157EN1
Issuing Agency: HIBCC
Commercial Distribution End Date: June 23, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Tetric CAD for CEREC HT I12 A1, Tetric CAD for CEREC HT I12 A2, Tetric CAD for CEREC HT I12 A3, Tetric CAD for CEREC MT C14 A1, Tetric CAD for CEREC MT C14 A2, Tetric CAD for CEREC MT C14 A3, Variolink Esthetic DC Neutral, Adhese Universal VivaPen, OptraPol Test Pack, various accessories

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?
62817	Dental appliance fabrication material, combination-material	A dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] 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
EBF	MATERIAL, TOOTH SHADE, RESIN

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: 88b5b524-19c1-47e2-970e-8adf3491363a
Public Version Date: June 24, 2022
Public Version Number: 4
DI Record Publish Date: September 27, 2018