AccessGUDID - DEVICE: Diamond (07898032320134)

GUDID

Device Identifier (DI) Information

Brand Name: Diamond
Version or Model: ACI & ACII
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4000002090
Company Name: Dentscare Ltda

Primary DI Number: 07898032320134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 898067533 *Terms of Use

Device Description: The polishing pastes Diamond ACI and ACII combine in their formulation the lubricating properties of Carbowax and abrasives, which for the ACI paste has medium grit and for the ACII paste has fine grit. The AC I paste is indicated for the grinding and finishing of the surface stage and the AC II paste is indicated for a polishing preliminary to the main polishing for shine with the pastes of specific use, according to the material being polished.

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:	No
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 93c241b5-7856-410f-845c-d252d516feff
Public Version Date: June 09, 2022
Public Version Number: 1
DI Record Publish Date: June 01, 2022