DEVICE: PERMITE (DO3640024642)
Device Identifier (DI) Information
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? |
---|---|---|---|---|
34836 | Dental amalgam alloy |
A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EJJ | Alloy, amalgam |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K801639 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Atmospheric Pressure: less than 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
62af5d0b-1f89-46bd-bfcb-8f692fb0085e
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
DO3640024640
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+18002285166
info@sdi.com.au
info@sdi.com.au