DEVICE: Henry Schein (00304040005873)
Device Identifier (DI) Information
Henry Schein
1063732
In Commercial Distribution
1063732
HENRY SCHEIN, INC.
1063732
In Commercial Distribution
1063732
HENRY SCHEIN, INC.
Ortho Bracket Adhes Kit
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| Yes | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 34782 | Dentine bonding agent/set |
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
|
Active | false |
| 31750 | 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.
|
Active | false |
| 36153 | 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DYH | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| EBF | MATERIAL, TOOTH SHADE, RESIN |
| KLE | AGENT, TOOTH BONDING, RESIN |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between 10 and 24 Degrees Celsius |
| Special Storage Condition, Specify: Keep out of sun |
| Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Weight: 9 Gram |
| Device Size Text, specify: Sealant Resin |
| Total Volume: 6 Milliliter |
| Device Size Text, specify: Single-Use Predosed Tip x 40 |
| Device Size Text, specify: Ethcant |
| Weight: 0.35 Gram |
Device Record Status
3250172b-0b0f-44de-93fc-d8d5cf45af30
February 16, 2024
3
September 24, 2016
February 16, 2024
3
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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
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
[?]
No Customer Contact currently defined