FDA UDI
In Commercial Distribution
🇺🇸 United States
PIVOT Fine Cherry Prophy Pack Box 100
DI: D0241100063
·
Model: 1100063
·
Preventech
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- PIVOT Fine Cherry Prophy Pack Box 100
- Primary DI
- D0241100063
- Version / Model
- 1100063
- Catalog Number
- 1100063
- Company Name
- Preventech
- Labeler DUNS
- 090735093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-06-13
- Public Version
- 1
- Public Version Date
- 2023-06-21
- Public Version Status
- New
- Public Device Record Key
- 126989af-84cc-4cb4-8a60-3d62f7f608c2
Device Description
PIVOT Fine Cherry Prophy Pack Box of 100 units each containing 1 Pivot Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NEXT Fine Cherry Prophy Paste
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
| EHK | Cup, Prophylaxis | Dental | 872.6290 | 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 |
| 46938 | Dental polishing cup, single-use | A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | D02411000633 | HIBCC | ||||
| Primary | D0241100063 | HIBCC |
Customer Contacts
- Phone
- 7048492416
- [email protected]