AccessGUDID - DEVICE: Laser Ceramic Yellow PdF (D707NA11948040)

GUDID

Device Identifier (DI) Information

Brand Name: Laser Ceramic Yellow PdF
Version or Model: NA1194804
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NA1194804
Company Name: IVOCLAR VIVADENT, INC.

Primary DI Number: D707NA11948040
Issuing Agency: HIBCC
Commercial Distribution End Date: June 22, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 176935203 *Terms of Use

Device Description: Laser Ceramic Yellow PdF .5mm Wire

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?
38780	Dental brazing alloy	A mixture of metals, usually in the form of a thin rod, used to braze cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the brazing metal melts around the joint to create the fusion. The brazing process operates at higher temperatures than soldering. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJT	Alloy, gold-based noble metal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: a0a74d80-bfbd-4917-b8dd-3fe1343e02ce
Public Version Date: June 23, 2021
Public Version Number: 2
DI Record Publish Date: October 29, 2018