DEVICE: Prima Titanium Implant 3.3mmd/11.5mml (07290112765901)
Device Identifier (DI) Information
Prima Titanium Implant 3.3mmd/11.5mml
A
Not in Commercial Distribution
111133
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
A
Not in Commercial Distribution
111133
DMI INNOVATIVE MEDICAL TECHNOLOGY LTD
"PRTI - is a self-tapping titanium dental implant, pronounced conical shape, with variable thread, with internal Hex2.43 connection. Implants are made of medical titanium alloy Ti6Al4V ASTM-136. Implants are available in diameter 3.3; 3.75; 4.2; 5.0; 6.0 mm in diameter and length 5; 6; 7; 8; 10; 11.5; 13; 16mm. The outer surface of the implant undergoes double treatment (sandblasting and acid treatment). The texture of the outer surface of the implant has micropores of 1-4 microns in size and macropores of 30-40 microns in size. The external thread of the implant has a double spiral shape. The internal connection of the implant - a internal hexagon 2.43 mmd and internal thread 1-72 UNF for all diameters. Implant complete with disposable carrier-441113 (441113S for 5-7mm short implants) and titanium cover screw-720638 (720638S for 5-7mm short implants). Used in all types of jaws. Recommended for bones of type D1, D2, D3. Implant areas - all parts of the upper and lower jaw. Indications - two-stage implantation."
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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K160060 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 11.5 Millimeter |
Outer Diameter: 3.3 Millimeter |
Device Size Text, specify: Internal Hex 2.43 mmd |
Device Record Status
7a3c1370-afe2-480e-9b03-90a8e2633436
January 25, 2023
1
January 17, 2023
January 25, 2023
1
January 17, 2023
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
19172798318
info@dmimplant.com
info@dmimplant.com