AccessGUDID - DEVICE: PIVOT Coarse Adult Variety Prophy Pack Box 100 (D0241100143)

GUDID

Device Identifier (DI) Information

Brand Name: PIVOT Coarse Adult Variety Prophy Pack Box 100
Version or Model: 1100143
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100143
Company Name: Preventech

Primary DI Number: D0241100143
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 090735093 *Terms of Use

Device Description: PIVOT Coarse Adult Variety Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Coarse Grit Prophy Paste (Cinnamon, Chocolate Mint, or Mint flavor)

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
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHK	Cup, Prophylaxis
EJR	Agent, Polishing, Abrasive, Oral Cavity

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100539	000
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: 433e03a9-afb0-46a3-bce3-8fe84d9ae7af
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023