DEVICE: SmartPractice (D766SP6931321)
Device Identifier (DI) Information
SmartPractice
SP693132
In Commercial Distribution
SP693132
Smarthealth, Inc.
SP693132
In Commercial Distribution
SP693132
Smarthealth, Inc.
S/P IMPRESSION MATL VPS MED BODY FS 50ML*4 #VP9009
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
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 [?] |
---|---|
K801380 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Humidity: between 65 and 80 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
be792d12-32b9-4187-9ae2-d774cf62d044
July 06, 2018
3
September 15, 2016
July 06, 2018
3
September 15, 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 |
---|---|---|---|---|---|
D766SP6931322 | 10 | D766SP6931321 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D766SP6931320
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1800-522-0800
jbankes@smarthealth.com
jbankes@smarthealth.com