DEVICE: Renew Finishing System (D798RSPFG0)
Device Identifier (DI) Information
Renew Finishing System
*RSP
In Commercial Distribution
*RSP
RELIANCE ORTHODONTIC PRODUCTS INC
*RSP
In Commercial Distribution
*RSP
RELIANCE ORTHODONTIC PRODUCTS INC
The Renew® Finishing System is intended for use in the removal of composite paste after debonding and polishing of the surface of enamel, porcelain, metal or composite.
The Renew Finishing System Points #383 will remove small residual amounts of adhesive from the tooth surface and will polish the enamel without damage. It's rubberized tapered shape facilitates removal of adhesive close to the gingiva.
The #383 Point is the second step in the Renew Finishing System Points.
This is the Friction Grip Finishing Point.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
16668 | Carbide dental bur, reusable |
A rotary cutting device made of high-grade steel, the working end of which is made from, or coated with, tungsten carbide, and which is designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, e.g., teeth or bone. It can also be used to cut hard metals, plastics, porcelains and similar materials. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EJL | Bur, Dental |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
af0fab77-9b07-4857-812e-54d46b6a5d95
March 23, 2020
3
April 30, 2018
March 23, 2020
3
April 30, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D798RSPFG3 | 3 | D798RSPFG0 | In Commercial Distribution | ||
D798RSPFG2 | 2 | D798RSPFG0 | In Commercial Distribution |
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