FDA UDI
In Commercial Distribution
🇺🇸 United States
Zircate® Cleaning and Polishing Material - Prophy Paste
DI: D0026770010
·
Model: 677001
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zircate® Cleaning and Polishing Material - Prophy Paste
- Primary DI
- D0026770010
- Version / Model
- 677001
- Catalog Number
- 677001
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-19
- Public Version
- 1
- Public Version Date
- 2022-09-27
- Public Version Status
- New
- Public Device Record Key
- 246a8151-7155-49c6-abfe-ae0a47c8f303
Device Description
Zircate® Refill Package
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- 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 | D0026770010 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 tube (170g) |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight and store in a well-ventilated place.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Allow material to reach room temperature prior to use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Inadequate storage conditions may shorten the shelf life and may lead to malfunction of the product.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Should be stored with the original cap only.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Protect from moisture.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not use after expiration date.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze.