DEVICE: Micro Brush (D798MBSF1)
Device Identifier (DI) Information
Micro Brush
MBSF
In Commercial Distribution
MBSF
RELIANCE ORTHODONTIC PRODUCTS INC
MBSF
In Commercial Distribution
MBSF
RELIANCE ORTHODONTIC PRODUCTS INC
Intended for use in the application of sealant resins or paste to enamel or aligners. This is the Super Fine version of the Microbrush.
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? |
---|---|---|---|---|
35697 | Dental material application tool, single-use |
A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ECP | Instrument, Ligature Tucking, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at ambient conditions. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
42b0dbc1-0fda-4899-b86e-b4ae3b6e0a9e
November 08, 2018
3
August 05, 2016
November 08, 2018
3
August 05, 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 |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D798MBSF0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
630-773-4009
paulgropi@aol.com
paulgropi@aol.com