AccessGUDID - DEVICE: XiVE® (EFRI322596002)

GUDID

Device Identifier (DI) Information

Brand Name: XiVE®
Version or Model: 32259600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 25-9600
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: EFRI322596002
Issuing Agency: HIBCC
Commercial Distribution End Date: December 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: XiVE® TG Lab Set Gold Bar Coping

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
44881	Dental implant suprastructure kit	A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Storage, in the original packaging, at room temperature in a dry place away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b7b502b-2273-47e6-b9cf-09bc8a9b0e90
Public Version Date: December 01, 2020
Public Version Number: 6
DI Record Publish Date: October 24, 2015