FDA UDI
In Commercial Distribution
🇺🇸 United States
Diamond
DI: 07898032320134
·
Model: ACI & ACII
·
Dentscare Ltda
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Diamond
- Primary DI
- 07898032320134
- Version / Model
- ACI & ACII
- Catalog Number
- 4000002090
- Company Name
- Dentscare Ltda
- Labeler DUNS
- 898067533
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-01
- Public Version
- 1
- Public Version Date
- 2022-06-09
- Public Version Status
- New
- Public Device Record Key
- 93c241b5-7856-410f-845c-d252d516feff
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
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07898032320134 | GS1 |