AccessGUDID - DEVICE: Disposable Prophy Angles (D798DPA1)

GUDID

Device Identifier (DI) Information

Brand Name: Disposable Prophy Angles
Version or Model: DPA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DPA
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798DPA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: Disposable prophy angles are intended for use with Prophy Paste to clean, polish and restore enamel surfaces. Qty 144 per Box

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
EHK	Cup, Prophylaxis

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 ambient conditions

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcbf0fb4-3490-4caf-84fa-33dc6ea79951
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 10, 2016