DEVICE: Accessory Pack (D798PASACC0)

Device Identifier (DI) Information

Accessory Pack
PASACC
In Commercial Distribution
PASACC
RELIANCE ORTHODONTIC PRODUCTS INC
D798PASACC0
HIBCC

1
113170088 *Terms of Use
Accessory Pack for the Perfect A Smile Kit includes a spatula and 10 Superfine Microbrushes.
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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

[?]
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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4031b299-2c51-4285-a4e7-f637779a86c3
March 29, 2018
2
September 20, 2016
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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
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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