DEVICE: TatumSurgical/Tapered Implant (00083208040146)
Device Identifier (DI) Information
TatumSurgical/Tapered Implant
Tapered/4.0x14
In Commercial Distribution
IT 4.0 x 14mm
Suncoast Dental, Inc
Tapered/4.0x14
In Commercial Distribution
IT 4.0 x 14mm
Suncoast Dental, Inc
Tapered Dental Implant 4.0mm in diameter and 14mm in Length
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 4 Millimeter |
Device Size Text, specify: Tapered 4.0 mm Diameter x 14mm Length |
Length: 14 Millimeter |
Device Record Status
c36c50a4-2f0d-4862-ab9a-b0207788b92d
January 11, 2023
5
October 30, 2015
January 11, 2023
5
October 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(727)536-4880
tatumcompliance@gmail.com
tatumcompliance@gmail.com