AccessGUDID - DEVICE: Vario-Soft 3 zircon sv (EBRE430073280)

GUDID

Device Identifier (DI) Information

Brand Name: Vario-Soft 3 zircon sv
Version or Model: 43007328
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 43007328
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBRE430073280
Issuing Agency: HIBCC
Commercial Distribution End Date: April 02, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: Vario-Soft 3 zircon sv 1 Assortment

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):	No
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?
38577	Bar dental precision attachment	A small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGG	ATTACHMENT, PRECISION, ALL

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: f7fe35a0-4b97-44a2-9654-1b235b0b7205
Public Version Date: April 03, 2019
Public Version Number: 3
DI Record Publish Date: September 27, 2016