DEVICE: Restore (D798RESPP20)

Device Identifier (DI) Information

Restore
RESPP2
In Commercial Distribution
RESPP2
RELIANCE ORTHODONTIC PRODUCTS INC
D798RESPP20
HIBCC

1
113170088 *Terms of Use
Restore™ diamond polishing paste is intended for use in restoring an aesthetic polish on porcelain or ceramic surfaces following orthodontic appliance removal. 2g syringe of Paste
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Dental polishing cup, reusable A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
EJR Agent, Polishing, Abrasive, Oral Cavity
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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

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Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C)
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c2f89fce-21a1-4d24-9bc9-366d9257df59
March 29, 2018
2
August 06, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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