AccessGUDID - DEVICE: Enhance® PoGo® Polishing System (D0026620101)

GUDID

Device Identifier (DI) Information

Brand Name: Enhance® PoGo® Polishing System
Version or Model: 662010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 662010
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026620101
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 40
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: PoGo One Step Diamond Micro-Polisher, DISC Refill Package (40)

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?
35807	Dental abrasive disk, reusable	A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing 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. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable 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: Keep away from sunlight. Keep dry.
Storage Environment Temperature: between 10 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30 Polishing Discs

Device Record Status

Public Device Record Key: 866d6ad3-24a4-4c67-91f9-ca97470e9288
Public Version Date: March 23, 2020
Public Version Number: 4
DI Record Publish Date: September 21, 2016