DEVICE: Micro Brush (D798MBSF1)

Device Identifier (DI) Information

Micro Brush
MBSF
In Commercial Distribution
MBSF
RELIANCE ORTHODONTIC PRODUCTS INC
D798MBSF1
HIBCC

100
113170088 *Terms of Use
Intended for use in the application of sealant resins or paste to enamel or aligners. This is the Super Fine version of the Microbrush.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dental restorative material applicator A hand-held manual dental instrument in the form of a rod of flexible metal or synthetic polymer material intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient?s tooth/teeth. It may be brush-like in design. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
ECP Instrument, Ligature Tucking, Orthodontic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store at ambient conditions.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

42b0dbc1-0fda-4899-b86e-b4ae3b6e0a9e
March 29, 2018
2
August 05, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: D798MBSF0 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
630-773-4009
paulgropi@aol.com
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