AccessGUDID - DEVICE: Zircate® Cleaning and Polishing Material

GUDID

Device Identifier (DI) Information

Brand Name: Zircate® Cleaning and Polishing Material - Prophy Paste
Version or Model: 677001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 677001
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026770010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Zircate® Refill 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:	No
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 10 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight and store in a well-ventilated place.
Special Storage Condition, Specify: Allow material to reach room temperature prior to use.
Special Storage Condition, Specify: Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
Special Storage Condition, Specify: Should be stored with the original cap only.
Special Storage Condition, Specify: Protect from moisture.
Special Storage Condition, Specify: Do not use after expiration date.
Special Storage Condition, Specify: Do not freeze.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 tube (170g)

Device Record Status

Public Device Record Key: 246a8151-7155-49c6-abfe-ae0a47c8f303
Public Version Date: September 27, 2022
Public Version Number: 1
DI Record Publish Date: September 19, 2022