DEVICE: Polysil Soft Putty Regular Set (07540196000581)
Device Identifier (DI) Information
Polysil Soft Putty Regular Set
SH-202
In Commercial Distribution
SH-202
Scican Ltd
SH-202
In Commercial Distribution
SH-202
Scican Ltd
Dental impression material to reproduce the structure of a patient's teeth and gums. Soft putty, regular set.
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 |
---|
Special Storage Condition, Specify: Store at normal room temperature (65°-73°F / 18°-23°C). |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8695a6de-3b60-46a2-aadf-60553c938e14
March 29, 2018
2
August 02, 2016
March 29, 2018
2
August 02, 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 |
---|---|---|---|---|---|
17540196000588 | 1 | 07540196000581 | In Commercial Distribution | Carton |
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
[?]
18006677733
tboyce@scican.com
tboyce@scican.com