AccessGUDID - DEVICE: Telio CS (DVIV628244AN1)

GUDID

Device Identifier (DI) Information

Brand Name: Telio CS
Version or Model: 628244AN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 628244AN
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV628244AN1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 26, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Telio CS CB A2, Mixing Tips, Telio CS Link Transparent, Mixing Tips, Telio CS Desensitizer, Application Brushes, var. 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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	CROWN AND BRIDGE, TEMPORARY, 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: 85a23103-3416-4b07-bb92-e64ab017bf1d
Public Version Date: January 27, 2022
Public Version Number: 3
DI Record Publish Date: September 27, 2018