AccessGUDID - DEVICE: PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144 (D0241100033)

GUDID

Device Identifier (DI) Information

Brand Name: PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box 144
Version or Model: 1100033
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100033
Company Name: Preventech

Primary DI Number: D0241100033
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 090735093 *Terms of Use

Device Description: PIVOT Non-Latex Disposable Prophy Angle Taper Brush Box of 144 single use taper brushes for dental 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?
64015	Dental-professional prophylaxis brush, single-use	A non-sterile rotary dental instrument with natural or synthetic bristle brushes intended to be used by a dental hygienist and/or dentist to clean and polish teeth. It is designed to be attached to a powered dental handpiece which provides the necessary rotation. 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: 6810f1c6-3523-4418-b73b-fa66b8af0638
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023