DEVICE: Diamodent (D907Y6650)
Device Identifier (DI) Information
Diamodent
N/A
In Commercial Distribution
Y665
DIAMODENT INC
N/A
In Commercial Distribution
Y665
DIAMODENT INC
Compatible with: 4.1mm Regular Neck (RN), & 4.8mm Wide Neck (WN) ITI Straumann implants
Abutment Screw, Titanium
SCS
35 Ncm
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
61647 | Dental prosthesis/implant abutment screw |
A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.
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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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0c534b04-7c86-4c24-bfd8-3f0cf13cee8b
September 22, 2020
2
January 04, 2019
September 22, 2020
2
January 04, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D907Y6652 | 12 | D907Y6650 | In Commercial Distribution | Pouch | |
D907Y6651 | 6 | D907Y6650 | In Commercial Distribution | Pouch |
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