AccessGUDID - DEVICE: Renew (D798RSPL1)

GUDID

Device Identifier (DI) Information

Brand Name: Renew
Version or Model: RSPL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RSPL
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798RSPL1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 12
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 and polishing of the surface of enamel, porcelain, metal or composite. This is the Latch Renew Finish Point.

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:	Yes
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?
58073	Polymeric dental bur	A rotary device intended to be attached to a slow speed dental handpiece that provides the rotation to enable the device to remove infected/decayed dentin without harming healthy zones of dentin. It is made of glass-bead-reinforced polymer or polyetheretherketone (PEEK) designed to deform on encountering harder, healthy dentin. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHL	Point, Abrasive

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8e7fd14a-8555-4543-a13d-22fffe3872e7
Public Version Date: March 23, 2020
Public Version Number: 4
DI Record Publish Date: September 04, 2016