AccessGUDID - DEVICE: Tatum Surgical/One Piece crown and bridge head implant (00083208150111)

GUDID

Device Identifier (DI) Information

Brand Name: Tatum Surgical/One Piece crown and bridge head implant
Version or Model: One Piece/5.0 x 11CB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ITO5.0x11CB
Company Name: Suncoast Dental, Inc

Primary DI Number: 00083208150111
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 5.0mm diameter and 11mm in length crown and bridge 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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 11 Millimeter
Outer Diameter: 5 Millimeter
Device Size Text, specify: One Piece 5.0mm Diameter x 11mm Length CB

Device Record Status

Public Device Record Key: b7d7a687-779c-49c5-81f5-6abb0eafc7ec
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 30, 2015