AccessGUDID - DEVICE: Implant-One (D762IR44012000)

GUDID

Device Identifier (DI) Information

Brand Name: Implant-One
Version or Model: IR4-4012-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Implant Logistics, Inc.

Primary DI Number: D762IR44012000
Issuing Agency: HIBCC
Commercial Distribution End Date: July 20, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079280537 *Terms of Use

Device Description: 400 Series Standard Thread, Root Form Implant, 4mm Diameter x 12mm Length. Included with the implant is the matching, sterile packed, carrier and cover screw.

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):	No
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?
55849	Screw endosteal dental implant, two-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 two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7560a5bf-7983-4a03-af1c-6d52e1fe2b51
Public Version Date: July 22, 2024
Public Version Number: 5
DI Record Publish Date: August 20, 2020