AccessGUDID - DEVICE: TatumSurgical/D Implant (00083208610165)

GUDID

Device Identifier (DI) Information

Brand Name: TatumSurgical/D Implant
Version or Model: D4S - Fin/4.5x10.0x16
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ID4S 4.5x10.0x16
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208610165
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: D4S Fin Implant 4.5mm neck diameter, 10.0mm fin width and 16mm in length

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
55846	Blade 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 narrow, wedge-shaped structure that is implanted into bone (typically includes lateral vents for tissue ingrowth), 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 [?]
K811923	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 16 Millimeter
Device Size Text, specify: D4S - Fin Implant 4.5mm Diameter x 10.0mm width x 16mm Length
Outer Diameter: 4.5 Millimeter
Width: 10 Millimeter

Device Record Status

Public Device Record Key: 4dea1c77-1fb5-49f0-9132-e4f4c6f8a75d
Public Version Date: January 03, 2023
Public Version Number: 5
DI Record Publish Date: October 30, 2015