DEVICE: 5mm Offset Shielded 15 Degree Abutment (D7855250TSIS0)
Device Identifier (DI) Information
5mm Offset Shielded 15 Degree Abutment
Offset Shielded 15 Degree Abutment
In Commercial Distribution
5250 TSI S
OCO BIOMEDICAL INC
Offset Shielded 15 Degree Abutment
In Commercial Distribution
5250 TSI S
OCO BIOMEDICAL INC
5mm Diameter Offset Shielded 15 Degree Abutment
Short
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
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Dental implant system | A collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation. |
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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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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No Device Sizes |
Device Record Status
f76c79cb-fa33-4cbb-9c97-dcc0740c2060
March 29, 2018
2
March 22, 2016
March 29, 2018
2
March 22, 2016
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
[?]
No Customer Contact currently defined