FDA UDI
In Commercial Distribution
🇺🇸 United States
Denticator
DI: 00302730000337
·
Model: 501350
·
YOUNG DENTAL MANUFACTURING I, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Denticator
- Primary DI
- 00302730000337
- Version / Model
- 501350
- Catalog Number
- 501350
- Company Name
- YOUNG DENTAL MANUFACTURING I, LLC
- Labeler DUNS
- 006309355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-16
- Public Version
- 2
- Public Version Date
- 2022-11-09
- Public Version Status
- Update
- Public Device Record Key
- 3fc221d8-08e6-46ba-96de-07c50595e925
Device Description
Denticator DPA Green, Latex Free, Soft, Short, Green Web Cup, Snap On Type
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| EGS | Handpiece, contra- and right-angle attachment, dental | Dental | 872.4200 | 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 | 10302730000334 | GS1 | Box | 500 | In Commercial Distribution | |
| Primary | 00302730000337 | GS1 | ||||
| Package | 20302730000331 | GS1 | Case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800) 325-1881
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 49 Degrees Celsius