DEVICE: Bond Aligner Tips (D798BATIPS1)

Device Identifier (DI) Information

Bond Aligner Tips
BATIPS
Not in Commercial Distribution
BATIPS
RELIANCE ORTHODONTIC PRODUCTS INC
D798BATIPS1
HIBCC
November 01, 2016
5
113170088 *Terms of Use
Bond Aligner® tips are 22 gauge dispensing tips designed for use with the Bond Aligner adhesive. Contains 5 tips per bag.
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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 cannula, single-use A non-sterile, rigid or semi-rigid device (dental tip) intended to channel a dental restorative material (e.g., amalgam, resin) from a single-barrelled parent device (e.g., syringe) to the intended site of dental application. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KXR Applicator, Resin
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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

1418e35b-229f-45cb-840a-912e3a3cf81f
March 29, 2018
2
July 18, 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

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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: D798BATIPS0 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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