AccessGUDID - DEVICE: Vitallium® (D001N001230)

GUDID

Device Identifier (DI) Information

Brand Name: Vitallium®
Version or Model: Special Alloy
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N001230
Company Name: Dentsply International Inc.

Primary DI Number: D001N001230
Issuing Agency: HIBCC
Commercial Distribution End Date: June 03, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 606173334 *Terms of Use

Device Description: No description.

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:	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?
42352	Subperiosteal dental implant material	A non-sterile material intended to be used, typically within a dental laboratory, to create a subperiosteal dental implant. It is typically in the form of a metallic ingot (e.g., titanium, cobalt-chrome-molybdenum) intended to be custom moulded for surgical implantation between the periosteum and the surface of the bone (subperiosteal frame) to provide support and a means of retention for a dental prosthesis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ELE	IMPLANT, SUBPERIOSTEAL

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
Weight: 500 Gram

Device Record Status

Public Device Record Key: 6d968fba-bca7-4671-844f-3e48a5bb09e5
Public Version Date: February 13, 2023
Public Version Number: 2
DI Record Publish Date: June 30, 2018