AccessGUDID - DEVICE: Tatum Surgical/One Piece small ball head implant (00083208235146)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Surgical/One Piece small ball head implant
Version or Model: One Piece/3.5 x 14SB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITO 3.5 x 14mm (SB)
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208235146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: One Piece Dental Implant 3.5mm diameter and 14mm in length small ball head

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?
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: One Piece 3.5mm Diameter x 14mm Length SB
Outer Diameter: 3.5 Millimeter
Length: 14 Millimeter

Device Record Status

Public Device Record Key: da21d76f-ace4-4665-8d6e-4a64b8b2be98
Public Version Date: January 11, 2023
Public Version Number: 5
DI Record Publish Date: October 30, 2015