AccessGUDID - DEVICE: Enhance® PoGo® Polishing System (D0026620241)

GUDID

Device Identifier (DI) Information

Brand Name: Enhance® PoGo® Polishing System
Version or Model: 662024
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 662024
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026620241
Issuing Agency: HIBCC
Commercial Distribution End Date: June 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Enhance® PoGo® Sample 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):	Yes
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
Storage Environment Temperature: between 10 and 27 Degrees Celsius
Special Storage Condition, Specify: Dry storage is recommended.
Special Storage Condition, Specify: Do not use after expiration date.
Special Storage Condition, Specify: Avoid direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Polishing Disc, 1 Polishing Point, 1 Polishing Cup

Device Record Status

Public Device Record Key: ff6ce26a-f5ea-4e55-a37c-a47105e89a09
Public Version Date: June 03, 2024
Public Version Number: 3
DI Record Publish Date: October 13, 2022