Tatum Surgical/Integrity Implant

Basic Information

• Brand Name: Tatum Surgical/Integrity Implant
• Primary DI: 00083208480201
• Version / Model: Integrity/8.0x20
• Catalog Number: ITI 8.0 x 20mm
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-18
• Public Version: 2
• Public Version Date: 2020-06-01
• Public Version Status: Update
• Public Device Record Key: 1fecc511-8663-4b6f-9b38-d70bfcd9256b
• Distribution End Date: 2020-05-29

Device Description

Integrity Dental Implant 8.0mm in diameter and 20mm in length

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZE	IMPLANT, ENDOSSEOUS, ROOT-FORM	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208480201	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K811923	000

Device Sizes

Type	Value	Unit	Text
Length	20	Millimeter
Outer Diameter	8	Millimeter
Device Size Text, specify			Integrity Dental Implant 8.0mm in diameter and 20mm in length