DEVICE: Renew (D798RSPHP1)

Device Identifier (DI) Information

Renew
RSPHP
In Commercial Distribution
RSPHP
RELIANCE ORTHODONTIC PRODUCTS INC
D798RSPHP1
HIBCC

12
113170088 *Terms of Use
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. This is the Handpiece Renew Finishing System Point.
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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
Polymer resin dental bur A non-cutting rotary device made of glass-bead-reinforced polymer designed to fit into a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming the healthy zones of dentin as intended. It is intended to reduce the risk of pulp exposure as its blades deform as they encounter harder, healthy dentin; it may be used especially for patients who do not tolerate or refuse anaesthesia. This is a non-sterile single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
EHL Point, Abrasive
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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

20b3354a-519d-4a51-b439-dc61bfa3bfe8
March 29, 2018
2
September 04, 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

[?]
Unit of Use DI Number: D798RSPHP0 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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