AccessGUDID - DEVICE: XiVE® (EFRI322524402)

GUDID

Device Identifier (DI) Information

Brand Name: XiVE®
Version or Model: 32252440
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 25-2440
Company Name: Dentsply Implants Manufacturing GmbH

Primary DI Number: EFRI322524402
Issuing Agency: HIBCC
Commercial Distribution End Date: December 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 344038836 *Terms of Use

Device Description: XiVE® TG plus Implant D3.8/L8

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?
55848	Screw endosteal dental implant, one-piece	A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.	Active	true

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 8ce8f5f7-a5f6-4a0a-899a-6b81c81d6a4f
Public Version Date: December 07, 2020
Public Version Number: 3
DI Record Publish Date: October 24, 2015