AccessGUDID - DEVICE: Enhance® PoGo® Polishing System (D002662025Y1)

GUDID

Device Identifier (DI) Information

Brand Name: Enhance® PoGo® Polishing System
Version or Model: 662025Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 662025Y
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D002662025Y1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Enhance® PoGo® Refill Package

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
64617	Dental abrasive disk, single-use	A dental instrument consisting of a circular flat or slightly conical sheet, which may carry or contain an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations (e.g., dentures, fillings, crowns). It is designed to be fixed at its centre to a laboratory mandrel or lathe, and/or intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZP	INSTRUMENT, DIAMOND, DENTAL

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: Dry storage is recommended.
Storage Environment Temperature: between 10 and 27 Degrees Celsius
Special Storage Condition, Specify: Avoid direct sunlight.
Special Storage Condition, Specify: Do not use after expiration date.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 Polishing Discs, 10 Polishing Points, 10 Polishing Cups

Device Record Status

Public Device Record Key: 56b21a77-7281-48cb-bc07-1a1a3e8b8e46
Public Version Date: October 21, 2022
Public Version Number: 1
DI Record Publish Date: October 13, 2022