DEVICE: Henry Schein (00304040005811)
Device Identifier (DI) Information
Henry Schein
1065167
In Commercial Distribution
1065167
HENRY SCHEIN, INC.
1065167
In Commercial Distribution
1065167
HENRY SCHEIN, INC.
Ortho Bracket Adhes Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Orthodontic bracket adhesive | A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused. |
Dental etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | AGENT, TOOTH BONDING, RESIN |
DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep out of sun |
Storage Environment Temperature: between 35 and 50 Degrees Fahrenheit |
Storage Environment Temperature: between 2 and 10 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 9 Milliliter |
Device Size Text, specify: Etching Agent |
Weight: 9 Gram |
Device Size Text, specify: Primer |
Device Size Text, specify: Single-Use Predosed Tip x 27 |
Weight: 0.35 Gram |
Device Record Status
136eb0c6-ccb3-4600-9d49-f99121cb8ee4
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined