AccessGUDID - DEVICE: NUPRO® Prophylaxis Paste with Fluoride (D0038012121)

GUDID

Device Identifier (DI) Information

Brand Name: NUPRO® Prophylaxis Paste with Fluoride
Version or Model: 801212
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 801212
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0038012121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: NUPRO® Prophy Paste, Mint, Coarse, Single Box (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":	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?
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
Special Storage Condition, Specify: Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 2 Gram
Device Size Text, specify: 200 Cups, 1 Prophy Grip, 1 Ring

Device Record Status

Public Device Record Key: 32feb9e3-b013-4494-907d-29e5d5557342
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 21, 2016