AccessGUDID - DEVICE: First & Final (D798FF1)

GUDID

Device Identifier (DI) Information

Brand Name: First & Final
Version or Model: FF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FF
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798FF1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: First and Final Orthodontic Prophy Pumice is intended for use in cleaning the tooth surface prior to acid etching. 200 Individual Prophy Paste in cups

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?
46938	Dental polishing cup, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EJR	Agent, Polishing, Abrasive, Oral Cavity

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: Limitation: Store at room temperature (15-30 ◦ C )

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3dfd09d-befc-452e-98d5-6d66b783137e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 10, 2016