DEVICE: Restore (D798RESPP20)
Device Identifier (DI) Information
Restore
RESPP2
In Commercial Distribution
RESPP2
RELIANCE ORTHODONTIC PRODUCTS INC
RESPP2
In Commercial Distribution
RESPP2
RELIANCE ORTHODONTIC PRODUCTS INC
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
Yes | |
No | |
No | |
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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? |
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16184 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EJR | Agent, Polishing, Abrasive, Oral Cavity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature (15-30 Degrees C) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c2f89fce-21a1-4d24-9bc9-366d9257df59
March 29, 2018
2
August 06, 2016
March 29, 2018
2
August 06, 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 |
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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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com