DEVICE: Henry Schein (10304040051419)
Device Identifier (DI) Information
Henry Schein
1008047
In Commercial Distribution
1008047
HENRY SCHEIN, INC.
1008047
In Commercial Distribution
1008047
HENRY SCHEIN, INC.
Composite Spatulas Plastic
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? |
---|---|---|---|---|
62477 | Dental composite resin kit |
A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes composite resin material and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prosthesis. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KXR | APPLICATOR, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
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
5083894a-9bbb-47d2-8314-f30d3400f357
January 05, 2021
1
December 28, 2020
January 05, 2021
1
December 28, 2020
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:
00304040051412
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined