DEVICE: Diamodent (D907S9100)
Device Identifier (DI) Information
Diamodent
N/A
In Commercial Distribution
S910
DIAMODENT INC
N/A
In Commercial Distribution
S910
DIAMODENT INC
Compatible with: 5.7mm Platform Screw-Vent Zimmer implants
Implant Replica, Aluminum, Yellow
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
61640 | Dental implant abutment analog, laboratory |
A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DZE | Implant, Endosseous, Root-Form |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K010619 | 000 |
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
0266e439-c0a5-426d-8c85-7f12f20456d4
January 21, 2019
1
December 21, 2018
January 21, 2019
1
December 21, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D907S9102 | 12 | D907S9100 | In Commercial Distribution | Pouch | |
D907S9101 | 6 | D907S9100 | In Commercial Distribution | Pouch |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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