FDA UDI
In Commercial Distribution
🇺🇸 United States
PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144
DI: D0241133343
·
Model: 1133343
·
Preventech
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
144
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Basic Information
- Brand Name
- PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144
- Primary DI
- D0241133343
- Version / Model
- 1133343
- Catalog Number
- 1133343
- Company Name
- Preventech
- Labeler DUNS
- 090735093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- 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
- 277e0ae1-d064-4786-98c8-9f7559122ce8
Device Description
PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures
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 |
|---|---|---|---|---|
| EHK | Cup, Prophylaxis | Dental | 872.6290 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | D02411333433 | HIBCC | ||||
| Primary | D0241133343 | HIBCC |
Customer Contacts
- Phone
- 7048492416
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K951016 | 000 |