DEVICE: Capture (D745701031CAP00240)
Device Identifier (DI) Information
Capture
70-1031-CAP0024
In Commercial Distribution
70-1031-CAP0024
Prismatik Dentalcraft, Inc
70-1031-CAP0024
In Commercial Distribution
70-1031-CAP0024
Prismatik Dentalcraft, Inc
Heavy Crown Impression Material
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? |
---|---|---|---|---|
35866 | Silicone dental impression material |
An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | Material, Impression |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 4 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bf3e0d23-c4b0-4e0b-9861-cb193ac035c6
August 22, 2023
3
April 21, 2017
August 22, 2023
3
April 21, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D745701031CAP00051 | 20 | D745701031CAP00240 | In Commercial Distribution | Pack | |
D745701028CAP00041 | 2 | D745701031CAP00240 | In Commercial Distribution | Pack |
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
[?]
9494402629
Shelly.Harris@glidewelldental.com
Shelly.Harris@glidewelldental.com