AccessGUDID - DEVICE: Topex® Prophy Paste (D687AD30011FG1)

GUDID

Device Identifier (DI) Information

Brand Name: Topex® Prophy Paste
Version or Model: AD30011FG
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AD30011FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D687AD30011FG1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Topex® Prophy Paste - Cherry, Medium (Box of 200 Cups)

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:	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?
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	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: 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 20 and 25 Degrees Celsius
Special Storage Condition, Specify: Store at normal room temperature 20 - 25 degrees Celsius.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 200 cups, 1 prophy grip, 1 ring, 1 DFU

Device Record Status

Public Device Record Key: edd37230-7c70-44e7-8163-d66ac009bab3
Public Version Date: December 13, 2022
Public Version Number: 1
DI Record Publish Date: December 05, 2022