AccessGUDID - DEVICE: Nupro® Prophy Paste with Fluoride (D0036380281)

GUDID

Device Identifier (DI) Information

Brand Name: Nupro® Prophy Paste with Fluoride
Version or Model: 638028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 638028
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0036380281
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Nupro® Coarse Adult Variety Pack

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: Do not store above 25 degrees Celsius.
Special Storage Condition, Specify: Keep out of direct sunlight.

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: b0cc7782-5303-4c5d-8f4a-434eead15c55
Public Version Date: December 13, 2022
Public Version Number: 1
DI Record Publish Date: December 05, 2022