DEVICE: s-Clean TiN Half Coating Angled Abutment (08806169115584)
Device Identifier (DI) Information
s-Clean TiN Half Coating Angled Abutment
DSAA45251NHCT
In Commercial Distribution
DENTIS CO. ,LTD
DSAA45251NHCT
In Commercial Distribution
DENTIS CO. ,LTD
Dental Implant System / s-Clean TiN Half Coating Angled Abutment D4.5mm, Cuff0.8mm, Angulation25° / Non-Hex
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 |
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NHA | Abutment, Implant, Dental, Endosseous |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K171694 | 000 |
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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No Device Sizes |
Device Record Status
ddf774d6-f201-49ac-b6a0-5e52db2b61a1
May 26, 2021
6
February 23, 2018
May 26, 2021
6
February 23, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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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
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No Customer Contact currently defined