DEVICE: TatumSurgical/Tapered Implant (00083208060113)
Device Identifier (DI) Information
TatumSurgical/Tapered Implant
Tapered/6.0x11
In Commercial Distribution
IT 6.0 x 11mm
Suncoast Dental, Inc
Tapered/6.0x11
In Commercial Distribution
IT 6.0 x 11mm
Suncoast Dental, Inc
Tapered Dental Implant 6.0mm in diameter and 11mm in Length
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
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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? |
---|---|---|---|---|
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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Device Size Text, specify: Tapered 6.0 mm Diameter x 11mm Length |
Outer Diameter: 6 Millimeter |
Length: 11 Millimeter |
Device Record Status
c59d17a8-dfc7-4940-bc25-2d61b046976b
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