AccessGUDID - DEVICE: Tatum Surgical/One Piece Crown and Bridge Angled head implant (00083208330230)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Surgical/One Piece Crown and Bridge Angled head implant
Version or Model: One Piece/3.0x23 CBA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ITO3.0x23CBA
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208330230
Issuing Agency: GS1
Commercial Distribution End Date: June 18, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 078352849 *Terms of Use

Device Description: One Piece Dental Implant 3.0mm diameter and 23mm in length crown and bridge angled head

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?
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 [?]
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
Outer Diameter: 3 Millimeter
Length: 23 Millimeter
Device Size Text, specify: One Piece Dental Implant 3.0mm diameter and 23mm in length crown and bridge 15°(degree) angled head
Angle: 15 degree

Device Record Status

Public Device Record Key: b8720e17-f491-4922-98d7-b5dadb928419
Public Version Date: June 19, 2020
Public Version Number: 3
DI Record Publish Date: August 28, 2018