AccessGUDID - DEVICE: PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144 (D0241133343)

GUDID

Device Identifier (DI) Information

Brand Name: PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144
Version or Model: 1133343
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1133343
Company Name: Preventech

Primary DI Number: D0241133343
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 090735093 *Terms of Use

Device Description: PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures

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):	No
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 [?]
K951016	000

Device Exempt from Premarket Submission: No 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: 277e0ae1-d064-4786-98c8-9f7559122ce8
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023