AccessGUDID - DEVICE: Tetric Prime (DVIV745236WW1)

GUDID

Device Identifier (DI) Information

Brand Name: Tetric Prime
Version or Model: 745236WW
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 745236WW
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DVIV745236WW1
Issuing Agency: HIBCC
Commercial Distribution End Date: February 04, 2025
Device Count: 4
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: Tetric Prime Refill 10x0.25g A2, Tetric Prime Refill 10x0.25 T, Cavifil Injector Refill Redesign, OptraGloss Test Pack 2

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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	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: 78f31c28-8ff1-47f2-ab04-91240bac7179
Public Version Date: February 05, 2025
Public Version Number: 2
DI Record Publish Date: February 11, 2021