AccessGUDID - DEVICE: Enhance® Finishing System (D002624045X1)

GUDID

Device Identifier (DI) Information

Brand Name: Enhance® Finishing System
Version or Model: 624045X
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 624045X
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D002624045X1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Enhance Finishing System Disc Refill Package - Export Only

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
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between 10 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 30x finishing discs

Device Record Status

Public Device Record Key: b7c2fe73-c611-4665-bca9-20880af9ed18
Public Version Date: March 23, 2020
Public Version Number: 3
DI Record Publish Date: April 02, 2019