FDA UDI
In Commercial Distribution
🇺🇸 United States
Contours Disposable Prophy Angles Firm Cup
DI: 00723896010044
·
Model: 7042620
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
144
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Basic Information
- Brand Name
- Contours Disposable Prophy Angles Firm Cup
- Primary DI
- 00723896010044
- Version / Model
- 7042620
- Catalog Number
- 7042620
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 144
- Record Status
- Published
- Publish Date
- 2018-07-18
- Public Version
- 1
- Public Version Date
- 2018-08-20
- Public Version Status
- New
- Public Device Record Key
- 5a96d084-10f1-4138-97ee-a9a13363c196
Device Description
a smooth, sculpted, low-profile design to maximize patient comfort and posterior access. The thin-walled, webbed cups flare consistently with moderate pressure to polish all “contours” and reach deep into interproximal spaces. Permanently sealed construction eliminates drive shaft separation. Unique lubricated gearing provides high torque and quiet dependability. Firm white cups. Made without using natural rubber latex.
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
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- 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 |
|---|---|---|---|---|---|---|
| Package | 00723896010051 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00723896010044 | GS1 | ||||
| Unit of Use | 00723896008386 | GS1 |