AccessGUDID - DEVICE: Renew (D798RSB815)

GUDID

Device Identifier (DI) Information

Brand Name: Renew
Version or Model: RSB815
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: RSB815
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798RSB815
Issuing Agency: HIBCC
Commercial Distribution End Date: September 23, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: The Renew® Finishing System is intended for use in the removal of composite paste after debonding. Size 815, Lingual Bur

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJL	Bur, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at ambient conditions.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d3d18a5c-8b47-4394-858c-6f1ff2b9e738
Public Version Date: March 23, 2020
Public Version Number: 3
DI Record Publish Date: August 01, 2016